Senior Clinical Resume Samples

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Guide the recruiter to the conclusion that you are the best candidate for the senior clinical job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

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W Harber

Winifred

Harber

6254 Meggie Parks

Houston

+1 (555) 620 6031

6254 Meggie Parks

Houston

Phone

p +1 (555) 620 6031

Experience Experience

Houston, TX

Senior Clinical Applications Analyst

Houston, TX

Bartoletti-Turcotte

Houston, TX

Senior Clinical Applications Analyst

Supporting existing clinical applications including installing upgrades, providing enhancements and problem management
Assisting with development of plans, strategies and tactics for employee education to support new and existing system applications
Developing documentation for training, maintenance and support, including problem resolution and escalation decision trees
Resolving support issues according to Information Systems policies, providing documentation to Clinical Applications Analysts for future reference
Work well under pressure
Collaborating with the Applications Analysts to provide user training, conducting training sessions as necessary
Working with clinical representatives after the conclusion of IS projects to measure results of initiatives

San Francisco, CA

Senior Clinical Data Prgrming Lead

San Francisco, CA

McKenzie, Quigley and Weber

San Francisco, CA

Senior Clinical Data Prgrming Lead

Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS)
Builds clinical study database CRF screens per CRF Specifications provided by project team
Creates/Programs edit checks, special actions/functions, custom programs and derivations as per a DVS
Reviews specification documents created by study teams, such as data transformation specifications and programming specifications
Co-ordinates and manages study database updates and out of scope impacts as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
Co-ordinates and manages study database updates and out of scope impacts as specified per change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes

present

Los Angeles, CA

Senior Clinical Team Lead-work From Home

Los Angeles, CA

Baumbach-Hamill

present

Los Angeles, CA

Senior Clinical Team Lead-work From Home

present

Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects
Work directly with data management and project team to monitor site accrual and data retrieval
Provide regular site specific clinical status information to team members and project management
Assist with vendor management
Ensure TMF is set-up by CPA and maintained from study start to completion, perform regular audits of TMF documents
Track performance metrics for the study team (i.e., training, study visits, report and follow-up letter submission, and monitoring)

Education Education

Bachelor’s Degree in Biomedical Equipment Technology

Florida Atlantic University

Bachelor’s Degree in Biomedical Equipment Technology

Skills Skills

Proficiency in CDISC
In depth knowledge of clinical trial process and data management, clinical operations, and systems applications to support operations
Proficiency in Business computer skills
Excellent oral and written communication and presentation skills
Documentation skills
Trained in Data Standardizing
Demonstrated organizational skills to handle multiple competing priorities simultaneously across an assortment of projects and initiatives

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15 Senior Clinical resume templates

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Senior Clinical Document Specialist Resume Examples & Samples

Acts as mentor for CDT, providing training and support around clinical document management activities
Familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices. Current awareness of regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive)
Demonstrated ability to work independently, take initiative, complete tasks to deadlines
Experience mentoring other members of staff preferred

Senior Clinical Standards Specialist Resume Examples & Samples

Collaborates with Lead CISs and Standards Team Lead to identify and resolve issues impacting goal attainment
Contributes to the development of training programs to affected internal and external staff. May assist with delivering the training
Ensures CROs and Shire are deploying standards / coding guidelines
B.S. degree in a Scientific or related field is preferred
Minimum 5 years+ experience in Data Management/Programming/Statistics or other Clinical Reaserch related fields
Experience with at least one CDISC standards

Senior Clinical Supplies Associate Resume Examples & Samples

Demonstrates proficiency in utilization of appropriate internal Clinical Supply databases, such as the ClinApps suite of software to facilitate the supply and distribution of clinical material to investigators and return from same. Interacts with contractors and internal Shire customers to monitor progress and to troubleshoot when required
Leads distribution and return projects by collaborating with CS managers and by interfacing with Clinical Supplies Technologies Team to understand Shire Interactive Response Technology (IRT) and internal database standards and requirements
Provides project based input into (IRT) design and development for return functionality if used and leads user acceptance testing efforts
Facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate internal database software or IRT service. Interacts with contractors and internal Shire customers to monitor progress and to troubleshoot when required
Utilizes the internal database to manage Clinical Supply inventory for projects assigned. Compares periodically to vendor inventory to ensure accuracy and that final product reconciliation is accurately completed
Organize and lead periodic packaging vendor operational meetings in order to show proper project oversight by setting agenda, insuring operational issues are discussed and issuing minutes. Lead effort to resolve issues and discrepancies
Leads or participates in global supply or return process-improvement initiatives by interfacing with Global CS personnel, developing rational, and creating implementation plans for change
Minimum 5+ years Pharmaceutical Industry or contract Provider experience and applicable Clinical Supplies experience

Senior Clinical Trial Transparency Associate Resume Examples & Samples

70% - Internal and External Transparency and Data Sharing
Coordinates the compilation and posting of information and data for clinical trial registration, maintenance, and completion (e.g. results). Ensures compliance with posting activities with respect to current regulatory guidelines and timelines
Responsible for the timely registration and updates on clinicaltrials.gov, Shiretrials.com, and other national registries as required by applicable regulations and Shire SOPs
Coordinates clinical trial data entry into publicly available websites ensuring accurate, consistent, thorough, and on-time entries. May be responsible for data entry or may relay information to external venders
Coordinates the generation and distribution of Lay Results Summaries for Patients to principal investigators
Responsible for coordinating the redaction of confidential information from Shire documents to be publically posted, if applicable, including information posted to shiretrials.com, government agencies, and to other parties
Contribute to the creation of SOPs and work instructions related to transparency activities, as needed
Assist the CTT manager and CTT team lead as needed on special disclosure and transparency projects
Coordinates the review, approval/rejection and data provision of patient level data requests received from independent researchers
20% - Metrics and Key Performance Indicators (KPIs)
Maintains reporting systems and metric reporting tools
Collaborate with clinical program teams and other functional areas to coordinate the collection and reporting of performance KPIs and other metrics
Compiles and distribute monthly and quarterly reports across all transparency activities
Responsible for coordinating or conducting quarterly quality control (QC) activities
10% - Aggregate Spend
Assists with development of department-specific data collection processes
Coordinates data collection and formal reporting activities for Global Clinical Development Operations
Coordinates submission into Shire’s reporting database
Coordinates with external vendors to develop and collect standard monthly payment reports
Works closely with internal support functions including Finance, and IT to ensure proper mechanisms are in place to capture required information globally
3-5 years relevant industry experience in quality, regulatory, compliance, clinical research, or drug development; clinical research experience preferred
Bachelor’s Degree in a life science required
Experience with data entry into clinical trial public websites preferred
Understanding of clinical trials, medical terminology, protocols and CSRs
Knowledge of global clinical trial transparency and data sharing requirements desirable
Strong comprehension of GCP, ICH guidelines, and applicable regulatory requirements for clinical research

Senior Clinical Document Management Specialist Resume Examples & Samples

70%:Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of CDO ensuring effective life cycle management of the clinical section of the Trial Master File (TMF)
Ensures effective communication and issue escalation internally and with external vendor
May fulfill the role of the Designated Clinical Archivist for GCDO
10%: Leads collaboration across R&D to agree study specific TMF. Oversees the consolidation of the R&D TMF across functions and external vendors at the end of the study
10%:Supports inspection readiness for GCDO through periodic quality assessment of clinical records
VEnsures clinical records are filed in a timely manner
VWith direction from the CDT Lead, prepares clinical records for agency inspection
VManages assigned TMF corrective action plans under direction of CDT Lead
10%:Represents CDT by presenting and training on document management processes to functional departments and external vendors
Supports CDT led initiatives to enhance efficiency in document management
Minimum 5 years of pharmaceutical industry experience related to clinical document management
Bachelor’s degree or equivalent preferred

Senior Clinical Document Management Specialist Resume Examples & Samples

Ensures clinical records are filed in a timely manner
With direction from the CDT Lead, prepares clinical records for agency inspection
Manages assigned TMF corrective action plans under direction of CDT Lead
10%: Represents CDT by presenting and training on document management processes to functional departments and external vendors

Senior Clinical Engineering Manager Resume Examples & Samples

Oversees hiring, placement and training for technicians and other staff within the CE department, while maintaining a strong focus on retention and team development
Implements human resources polices and procedures, including regular performance reviews and effective performance management, in a corporately responsible manner
Communicates, through the proper chain of command, critical information and decisions as appropriate, and responds to requests from Operations Director, Zone Vice President, and Corporate Staff
Develops and maintains strategic client relationships that foster business growth, establish regular communications and drive business outcomes
Manages program in compliance with Aramark’s Quality Performance Quotient (QPQ) and the account scope of service per the contract
Manages all facets of Aramark and hospital departmental budgets and financial reporting processes
Complies with all Aramark and Hospital reporting or approval processes
Minimum of 8 years experience in related field, with at least 5 years of supervisory experience
Financial Analysis and Interpretation
Management Skills

Senior Clinical Engineering Manager Resume Examples & Samples

Communicates, through the proper chain of command, critical information and decisions as appropriate, and responds to requests from District Manager, Regional Vice President, and Corporate Staff
Schedules and documents communication with client on a monthly basis, to include Quarterly Performance Reviews and Annual Performance Reviews, that focuses on marketing the accomplishments of Aramark
Bachelor’s degree required. Preference for degree in biomedical equipment technology, clinical engineering, or business

Senior Clinical Trial Leader Resume Examples & Samples

A minimum of a Bachelor’s Degree with at least 4 years of clinical or related technical experience required
The ability to influence others along with strong written and oral communication skills is required
Knowledge of Good Clinical Practices is required
Advanced project management skills with the ability to handle multiple projects required
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
This position is located in Irvine, CA and may require up to 25% travel.Clinical Research non-MD

Senior Clinical Administrative Director Resume Examples & Samples

Directs the development and implementation of the clinical department’s business strategy and market positioning in collaboration with the Keck Medical Center of USC and KSOM’s strategic plan. Performs on-going analysis of development of proposals of realistic business strategy for department. Develops and implements new programs and processes to enhance clinical operations and generate revenue through savings or income production. Reviews and approves all proposals submitted
Directs the overall finances of the department across all funding groups, dean’s allocations, research, county, clinical, outside contracts and hospital funding. Directs the funds flow in and out of the departments and provides oversight of all department expenditures. Establishes annual revenue goals for department. Develops annual budget with strategic plan highlighting a method for estimating revenue, revenue growth projections, and expense projections. Has signature authority for departmental accounts on all financial and payroll transactions. Makes major budgetary and resource allocation decisions. Analyzes financial data for trends and develops forecasts. Advises faculty and/or staff regarding budget preparation. Apprises Chair of the financial status of the department. Responsible for determining that the department has strong internal controls in areas such as maintaining and reviewing receipts, procurement, disbursements and payroll
Oversees the department’s clinical activities. Develops and monitors annual revenue goals for the department and monitors revenue cycle performance. Manages all faculty schedules to ensure that they are meeting their assigned clinical FTE and are aligned with AAMC benchmarks. Maintains a strong working relationship with the USC Care and the Hospital to actively manage utilization of the clinics and the operating rooms
Directs activities aimed at improving relationships with local physicians and retains and grows physician volume. Monitors inpatient with outpatient physician volume metrics on a monthly basis in conjunction with the hospital CEO, Medical Group CEO and the hospital administrative team. Discusses volume variances with physicians; establishes physician recruitment priorities based on alignment with the medical center’s strategic plan. Develops processes for successful physician recruitment and/or employment. Provides insight to cultivate and develop referral relationships with other facilities
Has responsibility for Medical School Operating Agreement (MSOA) stewardship including ensuring maintenance of daily accurate schedules for all services provided to LAC/USC. Provides oversight of twice annual Provider Time Study (PTS). Ensures departmental MSOA funds are used appropriately and department is compliant with all performance requirements (i.e., resident supervision, medical record completion, etc.). Informs Dean’s Office of any departmental issues related to the MSOA
Directly or indirectly manages all staff assigned to the department through subordinate professional staff. Determines organizational structure, reporting relationships and short and long-range staffing needs based on department goals. Reviews and recommends hiring and salary actions to the Keck School of Medicine to ensure compliance with policy. Oversees performance appraisal process for staff and remains informed of any disciplinary actions required. Provides general administrative oversight for department’s educational programs in conjunction with the Residency Director or the Vice Chair for education. Monitors all expenditures for department’s educational programs
Oversees the department’s research activities
Reviews and coordinates all faculty offers with the Office of Faculty Affairs. Manages on-boarding of faculty in terms of required dossier and appointment documents for academic appointment, payroll assignment of funding, demographic data, credentialing, etc. Determines organizational structures, reporting relationships and short and long-term staffing needs
Develops and maintains an effective communication program within the clinical department or division. Ensures the timely reciprocal exchange of information among top management, faculty and staff. Maintains effective communication and a strong working relationship with USCare and Hospital to actively manage utilization of clinics and operating rooms
Establishes and maintains appropriate network of professional contacts. Maintains currency through professional organizations and publications. Attends meetings, seminars and conferences; makes formal presentations

Senior Clinical Trial Leader Resume Examples & Samples

Ensure that all Human Resource related activities, and decisions embody the Johnson & Johnson Credo Values
Provide leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus
Ensure efficient use of resources within the clinical study/program to provide high quality deliverables
May lead several small/medium clinical trials (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve other clinical operations staff (i.e., >250K USD annual investment)
May assist with the management of large regulated or complex trials/program under supervision of CTM or Senior CTM
Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities
Reviews and provides feedback on clinical operation section of protocols with supervision
May plan budgets for single trials with supervision
Requires understanding of Good Clinical Practices
Understanding and application of regulations and standards applied in clinical areas/regions is required
Good presentation skills and effectively influencing of others
A minimum of a Bachelor’s Degree is required, preferably in Life Science, Physical Science, Nursing, or Biological Science
A BS with at least 4 years of experience, MS with at least 3 years of experience, or a PhD with at least 1 year of relevant experience is required
Previous experience in clinical trial management or equivalent is required
This position may require up to 30% travelClinical Trial Administration

Senior Clinical Study Assistant Resume Examples & Samples

Assist with implementing plan of care as delegated by the RN or physician
Determine specimen acceptability regarding proper containers and accurate patient identification
Demonstrate knowledge of scientific principles involved in direct patient related activities and diagnostic procedures
Enter demographic information as well as specimen quality into the computer system
Perform chemical analysis as needed

Senior Clinical Quality Auditor Resume Examples & Samples

Coordinates internal reviews on denial letters to determine compliance with contractual and regulatory requirements of the State Medicaid programs, while reviewing for efficiencies and effectiveness of procedures
Performs internal Quality Control reviews on processes and activities while developing recommendations for improvement
Serves as a catalyst for implementing an appropriate risk assessment process designed to identify and correct deficiencies
Assists with the coordination of external audits and reviews conducted by our clients or contracting organizations
Maintain extensive knowledge of regulatory and applicable accrediting body requirements becoming a Compliance resource for the team
Proficient in interpreting benefits, contracts, and medical policy
Review denial notice issued by the National Letter team to ensure accuracy and compliance, as well as providing recommendations for improvement, as needed
Interact effectively with other departments
Maintain knowledge of State rules, contracts, and Federal legislation/regulations as well as UHG guidelines
Establish and maintain good working relationships throughout the company to support goals and objectives
Unrestricted RN license required
Bilingual in English and Spanish; able to speak, read and write
Able to work Saturdays as needed between the hours of 9A - 3P
3+ years clinical experience in an Acute care environment
Proficiency using Microsoft products including Word, Excel and Outlook
Proven analytical and problem solving skills while managing multiple tasks simultaneously
Demonstrated excellent written and verbal communication skills required
The applicant should possess a high attention to detail, exceptional documentation abilities, and organizational skills
Proven ability to meet critical deadlines consistently, while completing tasks accurately
Proven ability to handle multiple tasks simultaneously by working independently, as well as part of a team, in a fast paced environment
Knowledge of MCG or Miliman Guidelines
Knowledge of State Medicaid Rules and Long Term Care
Managed care experience or experience with a regulatory or accredited body

Senior Clinical Quality Informatics Resume Examples & Samples

Serve as technical advisor and contributor to MITRE healthcare projects, specifically areas of relevance to HHS operating Divisions
Apply knowledge and expertise to project objectives to determine feasibility of target solutions
Determine the adequacy of the requirements, architecture, design, and implementation of target solutions, as well as systems integration and data interoperability
Determine technical specifications relative to standards-based healthcare information exchange
Support coordination and communication between key scientific and technical stakeholders to ensure direction and effectiveness of solution implementation
Significant work experience in scientific, technical, or related field-experience in biotechnology, diagnostics, CRO, or pharmaceutical industry preferred
Ability to present scientific topics to both technical and lay audiences, and to convey complex information clearly and concisely in both written and oral form-preference for those with demonstrable experience briefing executive level staff
Previous demonstrable experience collaborating across business or functional entities to accomplish cross-cutting objectives
Previous demonstrable in consulting, contracting, or other service related technical line of work strongly preferred

Senior Clinical Affairs Manager Resume Examples & Samples

Acts as Clinical Studies lead for the project to prepare protocols for the external verification and validation
Activities for one or more Pathology Imaging Systems projects
Participates in the decision making for site selection and will visit and qualify new sites, make interim and
Site close-out visits as appropriate
Initiates clinical trials and ensures sites’ readiness. Ships materials and investigational devices and tracks device
Responsible for the site monitoring plan. Participates in investigators meetings and escalates protocol
Deviations and site issues
Reviews data, enters data and supports the database management for the clinical trials. Works closely
With S/W engineers to optimize database parameters
Prepares data for analysis by Biostatistician and interacts with Study Monitors to ensure data audit are
Performed. Escalates and addresses any issues with data integrity
Prepares data summaries, reports and presentations for design reviews. Works with Regulatory Affairs to
Ensure data outputs and templates are adequate for submission
Supports preparation of manuscripts, technical articles based on clinical trials and external studies
Interacts and consults with inter-department team members
Bachelor of Science (B.S.) or Master of Science (M.S.) or Doctor of Philosophy (Ph.D.) in Histology, Microbiology, Biomedical Engineering or a related field
5+ years Clinical Affairs experience
Experience with or understanding of Pathology clinical workflow applications, or experience in IVD device clinical affairs
Clinical study management and monitoring for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment
Familiar with standards and regulatory requirements for design control and clinical trial management
Organizational, planning and detailed follow-up skills required
Experience working with data management tools and understanding of databases and general statistical concepts
Sufficient knowledge of clinical pathology, or preferably pathology imaging and image analysis laboratory evaluations to understand customer needs and to enable interaction with principal investigators, medical professionals and key opinion leaders. Able to secure appropriate internal or external technical expertise required and coordinate efforts to resolve technical issues that may arise during clinical trials
Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members
Ability to understand complex scientific, engineering and business concepts
Proven technical writing and presentation skills required
Demonstrated ability to meet project timelines

Senior Clinical Contracting Analyst With German Resume Examples & Samples

Perform Consistency Checks and corrective actions
Check contracts against defined procedures (e.g. Amendments stored correctly)
Execute and manage the contractual documents needed to effect the selection of the optimal external service provider (ESP)
Monitor and manage contracts from initial development to execution and other relevant KPI’s
Reporting (Contract owners, Category Managers)
Timely execution of agreements and identification of expiring contracts
Ensure compliance within a defined Control Framework according to the globally defined Contract Management Process
Standardization and continuous improvement in the contracting process
Fluent English and fluent German
Previous experience in drug development within the pharmaceutical industry or similar CRO or laboratory industry is highly desirable
Understanding of the clinical development process and understanding of the management of clinical trials
Familiarity with central labs, reference labs and specialty providers
Solid financial understanding as it relates to clinical trial contracts/cost elements
Strong demonstrated negotiation skills
Solid problem solving skills

Senior Clinical Trial Budget Manager Resume Examples & Samples

Manage budgetary requirements of clinical program, by providing consolidated latest estimates on current year budget and future year planning budget. Identify issues and propose mitigating plans for facilitating decision making. Identify productivity savings
Develop and agree on the trial budget with the clinical trial teams and assist with securing approvals. Initiate and lead resource review meetings. Challenge and track program/trial timelines, resource requirements and expenditures and initiate adjustments as needed. Liaise with the GPTD/ GBMD and other global line functions to assist clinical teams with securing sufficient resources
Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning. Liaison to global departments regarding forecasts and status of program timelines and resources
Track that program specific standards and metrics are developed and applied. Ensure processes are implemented consistently across the program(s)
Active member of International Clinical Team (ICT). Core member of CTT and PFT
Provide clinical trial process and budget training to clinical staff
Conduct training sessions and mentor new CTBMs to support clinical trial teams with the development of trial budget and operational strategy, and assist with securing approvals
Faculty member for OGD&GMA and OTM training programs, author or reviewer for clinical SOPs
Provide input to the development of process standards/tools and performance metrics to achieve excellence in OGD & GMA and OTM. Drive implementation to achieve results faster, economically and more effectively in cooperation with key stakeholders
Develop best practices for allocating and managing resources. Participate in cross-functional process improvement initiatives
Manage TCF/Study CPO costs and alignment with TTG
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At least 5 to 7 years of related experience in Drug Development in Pharmaceutical Industry or with a vendor/provider from Pharma
Excellent understanding of the clinical development process and the management of clinical trials
Strong knowledge of the CRO/Central Labs/Specialty Provider and investigator fees cost drivers
Superior understanding of common pricing and contracting models for clinical services
Strong clinical background and strong budgeting understanding (understanding of cost drivers and benchmarks for clinical trials) as it relates to contracts and cost reductions; ability to speak intelligently regarding cost drivers and comparative analyses
Experience in working with electronic databases, clinical and/or project management planning and reporting systems
Excellent written and oral communications skills
Excellent influencing and negotiating skills
Superior problem solving skills

Senior Clinical Account Leader Resume Examples & Samples

Minimum of 3 years’ experience directly supporting clinical research or related experience in a medical/scientific area (or MS or MBA with 2 years clinical research & regulatory experience)
B.A. or B.S. degree in Business, Marketing, Engineering, or Science
Medical device industry knowledge
Prior Sales or Account Management Experience
Prior experience in managing clinical trials
Proven ability to collaborate and to operate in a matrix organization and to work effectively with internal and external customers across geographic and organization boundaries
Results oriented. Demonstrates a sense of urgency and willingness to make tough decisions in short time frame
Ability to anticipate and to analyze risks and make strategic choices to balance current and long-term business opportunities
Demonstrated ability to effectively and persuasively communicate verbally and in writing; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills
Ability to learn quickly, with a recurring desire to acquire new skills and techniques

Senior Clinical Quality Spec Resume Examples & Samples

5+ years experience directly supporting clinical research within a regulated environment or quality or audit experience in a regulated environment (Master's and 4+ years)
Past or current experience developing policies and procedures in a clinical research environment
Experience auditing clinical studies
High attention to detail and accuracy
Proficient knowledge in FDA and international regulations (pharmaceutical and/or device) and/or experience in Quality Systems regulations
Strong interpersonal skills, ability to work with and lead teams and be a self-initiator
Proficient knowledge in MS Word. Basic knowledge in MS Excel

Senior Clinical Pharmacokineticist Resume Examples & Samples

Acts as a lead Pharmacokineticist on one or more studies and investigates, identifies, develops, and optimizes new PK/PD models
Develops productive collaborations and communications with other groups, across multiple disciplines
Contributes to the development of commercial and regulatory strategies by formulating PK/PD plans including development activities
Assists in the development of PK/PD plans to satisfy regulatory expectations and defend plans and interpretation of data to management
Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact)
Contributes to interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions
Author in peer-reviewed journals, R&D reports, and/or regulatory documents/filings
May contribute to due diligence

Senior Clinical Imaging Lead Resume Examples & Samples

Work with GCO and Imaging CROs in study site selection and qualification process
Contribute to the development and implementation of clinical research studies to identify innovative imaging biomarkers for early drug development
Liaise with GCO, Procurement, C&O groups to implement systems, processes, and procedures relating to imaging operation excellence
Liaise with GCO and Imaging CROs to develop and implement data transfer processes to ensure quality and timely transfer of required data
Lead operational training for imaging technologies. Prepare and provide training materials and education to the organization
Catalogue imaging technology requests from various therapeutic areas for future resource allocation strategy
LI-RD2

Senior Clinical Program Consultant Resume Examples & Samples

Regularly facilitate efficient, effective practice improvement meetings with the practice to monitor, present, and discuss progress on the transformation action plan and achievement in milestones
Consults with and guides the practice on developing innovative solutions, including bringing best practice experience and connecting practices with other high performing practices to spur innovation
Must have access to high speed internet for home office set up
Experience preparing and presenting information to clinical and executive level leadership
Clinical process improvement experience

Senior Clinical Trials Management Associate Resume Examples & Samples

Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas
At least 3+ years of experience and a BS or BA in a relevant scientific discipline
At least 3+ years of experience and an RN (2 or 3 year certificate)

Senior Clinical Trials Management Associate Resume Examples & Samples

Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required
Assures site compliance with the routine protocol and regulatory requirements and quality of data
Assists in the setting and updating of study timelines
Assists in CRO or vendor selection
With guidance from supervisor coordinates CROs or vendors
Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues
May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants
Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives
Applicable for biomarker operations
Plans and coordinates all operational activities required with the collection, delivery and analysis of biosamples within a clinical trial
Provides sample management expertise to the Study Management Teams (SMTs)
Accountable for ensuring biosamples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent
Collaborate with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting
Primary interface for operational activities between the SMT and
Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
Must have a general understanding of functional issues and routine project goals from an organizational perspective

Senior Clinical Trials Management Associate Resume Examples & Samples

4+ years of experience and a BS or BA in a relevant scientific discipline
4+ years of experience and an RN (2 or 3 year certificate)
CCRA or other certification desired

Senior Clinical Trials Management Associate Resume Examples & Samples

Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas
With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required
May participate in abstract presentations, oral presentations and manuscript development
Interfaces with individuals in other functional areas to address routine study issues
Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
Typically requires a BS or BA in a relevant scientific discipline and minimum 4 years direct CRA experience in the pharmaceutical industry or equivalent

Senior Clinical Trials Management Associate Resume Examples & Samples

Assist the CTM to organize and lead review/approval meetings for CO proposal
Able to anticipate obstacles and proactively develop solutions to achieve project goals
Develop a general understanding of functional issues and routine project goals from an organizational perspective
Interact and cooperate with individuals in other functional areas to address routine study issues
Develop tools and processes that increase measured efficiencies of the project
Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
For GS studies, assist in selecting Contract Research Organizations (CROs) or vendors
Assist with the setting and updating of study timelines
Participate in departmental, or interdepartmental, strategic initiatives under general supervision
Ensure that the site complies with the protocol and regulatory requirements for GS studies
For GS studies, draft and coordinate review of protocols, informed consents, case report forms, and monitoring plans

GCP, Senior Clinical Auditor Resume Examples & Samples

Prepare and conduct internal and external audits for Mylan
Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and impact on systems being audited
Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management
Provide interpretation of complex regulations through research of current corporate and governmental expectations
Perform Clinical internal and external audits based on a defined audit plan within specific time constraints, including the facilitation of opening and closing audit meetings with all levels of Management, the preparation of all associated documentation including audit plans and audit reports under strict confidentiality, and track and monitor audit responses and the implementation of corrective actions
Provide guidance and support in the development of corrective actions based on Clinical principles and current industry standards
Author and approve procedures and serve as a compliance reference regarding Clinical Interpretations for all levels of Management
Review, evaluate, and approve clinical audit reports. Serve as a liaison within the many Clinical departments of Mylan to effectively establish compliant quality systems
Plan, schedule, and arrange travel to various sites based upon guidance from Management
Minimum of a Bachelor’s degree (or equivalent) and 6 years of Clinical Operations and/or Audit. However, a combination of experience and/or education will be taken into consideration
40 percent domestic and international travel is required

Senior Clinical Trials Specialist Resume Examples & Samples

Liaise with Clinical Contract Specialists to collect and negotiate Confidentiality Agreements (CDA)
Organize translations per country requirements
Review and approve country and/or site specific documents or essential regulatory documents
Customize, review, configure and negotiate country/site specific Informed Consent Forms and their amendments
Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)
Must be detail oriented with strong organizational, time management and project management skills. Must be able to prioritize workload
Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside clinical operations, including upper management, vendor personnel, clinical investigators and site personnel
Demonstrated knowledge of GCP/ICH regulations and guidelines
Ability to handle high workloads, demanding situations, and deadlines

Senior Clinical Quality Supervisor Resume Examples & Samples

Supervise a team of staff responsible for outreaching members in need of preventative health services, including hiring, training, and evaluating staff performance
Design, create and implement Quality Improvement projects and initiatives designed to improve member access to care
Extract appropriate metrics from data bases used to analyze the health plan performance on key metrics
Conduct and manage outcomes of various studies that may include analyzing, reviewing, forecasting, trending, and presenting information for quality management planning and management needs
Master's degree in health services, public health, or health care administration and/or a CPHQ or CHCQM certification
Intermediate skill set to navigate Microsoft EXCEL Databases
Intermediate computer skills (Microsoft Word, Outlook and Internet) with the ability to navigate a Windows environment. Create, edit, save and send documents utilizing Microsoft Word
Previous experience with quality measures such as HEDIS

Senior Clinical Study Assistant Resume Examples & Samples

Complete all regulatory documents, including informed consent forms, IRB application and submission to regulatory agencies
Prepare and organize space for study related equipment and supplies. Travel between dialysis units and clinics
Maintain screening /enrollment /master subject logs
Process human blood samples by centrifuging blood and pipetting specimens into smaller tubes
Make copies, prepare transmittal sheets for mailings and send out documents as required for study implementation
Obtain screening information via phone or in person to determine eligibility for study. Obtain informed consent from patients
Extract data from source documents (medical record) and transcribe into electronic database

Senior Clinical Technology Manager Resume Examples & Samples

Under the Direction of the Regional Clinical Technology Director, is responsible for the integrated management, oversight, and direction of the Clinical Technology Managers/Staff/Integration Teams. Provides guidance and direction to Clinical Technology and other committee members that he/she does not directly manage, as well as providing team support and technical expertise. Directs the equipment management program (technology lifecycle management) by defining qualitative and quantitative metrics to measure the effectiveness and efficiency of the program
Establishes and maintains a means of identifying, monitoring and resolving issues related to clinical technologies that present a risk to care delivery. Provides routine updates to medical center leadership as well as Director of Clinical Technology. Identifies issues that require executive sponsorship for resolution. For these issues, develops recommendations and/or options for resolution. Also, Clinical System Engineers provides resources for medico-legal investigations involving clinical technology
Minimum eight (8) years of total experience in clinical technology
Minimum three (3) years of management experience in leading and managing Clinical Technology Groups in a multi-hospital/Large Hospital/multi-state environment
Minimum three (3) years of experience in a management role in a Clinical Technology environment
Minimum eight (8) years of total experience in clinical technology with regional responsibility preferred
Master's degree preferred (MBA, health administration)

Senior Clinical Services Analyst Resume Examples & Samples

Extracts and manipulates data from data sources, including but not limited to Sunquest, Clarity, Sybase Data Warehouse, and Oracle Data Warehouse using Crystal Reports, Business Objects, Infomaker, and SQL
Consults and works with Clinical Services Analytics Supervisor and lab/optical/pharmacy services management to develop and compile ad-hoc and standard reports
Develops databases and queries to compile reports and analyses in support of current program initiatives related to drug conversions, quality and formulary management, volume, productivity, turnaround time, cost, etc. as requested by Regional Clinical Services
Designs and prepares routine and special project reports including the design of decision support analyses, time/motion studies, clinical studies, protocol development analyses, pilot project and study analysis, and graphical presentations
Mentors and functions as a technical SME for entry level analysts, and serves as technical backup for the Analytics supervisor
Makes recommendations to management on the basis of reporting and analyses
Minimum two (2) years of experience designing and developing databases and queries using Microsoft Access
Minimum two (2) years of experience designing and developing spreadsheets and graphs using Microsoft Excel
Minimum two (2) years of experience designing relational databases
Minimum one (1) year of experience with SQL/Oracle
Minimum two (2) years of relevant experience in pharmacy or healthcare
Bachelor's degree in health care major preferred
Master's degree in business administration, health science administration OR two (2)years of experience in a directly related field
Knowledge of Business Objects

Senior Clinical Account Specialist Resume Examples & Samples

Minimize user turnover
Coordinate high attendance user meetings and Intro workshops
System utilization
Executing Diamond Rewards Program enrollment & tools to increase consumable usage
Execution of partnership activities tied to DRP levels
Generate cross-sell leads to existing customers for Capital Equipment Specialists (CES)
Develop business evaluations & reviews for listed accounts
Executing launch installation action plans for listed accounts
5+ years of industry experience
Minimum of 2 plus years work experience in a clinical or health care field. Experience in the cosmetic/aesthetic field is preferred
3+ years of proven success selling consumables and preference for experience with capital equipment
Preference for candidates who also have experience with consumable selling. 4-6 years of demonstrated success selling medical products or services to physicians and other health care providers. Preference for direct customer experience with the plastic surgeon and dermatologist audience
Ability to communicate effectively, in writing and orally, with all levels of employees
Ability to make effective and persuasive communications and technical presentations to physician’s management and/or large groups. Ability to thoroughly understand and communicate the attributes and qualities of Solta products using professional selling and closing skills
Valid driver’s license with a clean driving record
Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA GMPs
Excellent planning and organizational skills. Skilled in managing time effectively. Ability to be flexible in changing daily workload priorities as directed
Ability to maintain suitable work station (including inventory) in own residence
Ability to transport of up to 60 pounds of equipment within territory

Senior Clinical Admin Coordinator Resume Examples & Samples

Handle resolution / inquiries from members and/or providers that may include
HS Diploma or GED
Must be able to create, edit, save and send documents utilizing Microsoft Word and Excel
Experience working with Home Health and Pallative Care
Ability to manage Healthcare Programs for efficiency and to achieve goals
Ability to hold meetings in providers offices regarding industry and healthcare plan changes
Ability to troubleshoot Quality issues
Ability to trach and monitor programs and outcomes

Senior Clinical Administrative Assistant Resume Examples & Samples

Reports to the Director of Clinical Operations but has many external and internal customers
Administrative function include more traditional administrative / clerical support roles including: answering the telephone, typing / word processing of documents, maintaining calendars and setting up meetings/conferences, making travel arrangements, copying, faxing, greeting visitors, setting up files, tracking expenses, and ordering supplies. This position supports executives at the Sr. leadership team level and below
Update new member log daily
Manage Licenses, Certifications, and collaborative agreements
SharePoint updates
Update Biography cards
Obtain all new hire photos
Nurse Practitioner and RN Supply Ordering and Shipment
Sales Team back up with New Member Enrollment
Other ad hoc projects as needed
Minimum of 1 year of experience as an Administrative Assistant
Computer proficiency in Word, Excel, Power Point, Mail Merge, Outlook - intermediate level
Experience working in a healthcare setting

R&D Senior Clinical Production Operator Resume Examples & Samples

Perform routine and advanced duties required to make quality bulk and fill/finish drug product. Duties include: set up and execution of bulk manufacturing, CIP, SIP, solution prep, filter building and testing, as well as responsibility for set-up and preparation of the area for bulk manufacturing
Assist in drafting and revising of SOPs for Clinical Suite. Maintain SOPs post approval
Execute and review GMP documentation as required (Batch Records, Forms, Charts, SOPs, incident reports)
Read, comprehend, and adhere to standard operating procedures (SOPs)
Identify and communicate floor observations to supervisory staff. Perform basic troubleshooting
Proficient and fully trained in clean room gowning and cleanroom practices
Assist in maintaining the production areas and records in a cGMP state at all times
Adhere to all EH&S policies, procedures and guidelines
A minimum of 3 years of industry experience in the pharmaceutical or a closely-related industry required. However exceptions may be made based on relevant educational degree
A high school diploma/GED is required. Relevant experience may be substituted for diploma/GED requirement
The ability and willingness to work as a member of a team and possess good interpersonal skills
Ability to work with minimal direct supervision and is self-driven to meet the schedule
Must have good attention to detail, documentation skills and the ability to follow written procedures in a GMP environment
Must possess strong written and verbal English communication skills
Must have strong organizational skills and the ability to multi-task
Ability to operate in a clean room environment
Must understand and be proficient with basic arithmetic calculations, including calculating elapsed time and ratio calculations
Computer proficiency, including knowledge of Microsoft Word, Outlook, and Excel applications is required

Senior Clinical Data Prgrming Lead Resume Examples & Samples

Travel (approximately 15%) domestic and/or international
CDMS
Serves as the lead on study specific database design within the CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager), leading clinical database programming activities on multiple studies of complex design and expert in all areas for relevant CDMS
Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS)
Builds clinical study database CRF screens per CRF Specifications provided by project team
Creates/Programs edit checks, special actions/functions, custom programs and derivations as per a DVS
Plans and schedules edit check test script writing, edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File
Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
Configures study specific data interfaces such as IVRS, labs, and CTMS
Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources
Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS failures, CTMS issues), and/or change request issues using the appropriate applications
Ensures high quality deliverables by providing senior review of study-level/program -level I multi study core deliveries for accuracy
Maintain confidentiality of management information as appropriate
Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates)
Maintaining all necessary study documentation for the CRF build and edit checks
Contributes to training materials on a process, system or technology level. Works with ICON University and DM Management on delivery of training courses, instructor-led and on-the-job
Ensures programming processes are compliant with applicable SOPs
Respond to Business Development requests as required
Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and supervision of programmers, medical terminologists, and/or forms designers
Participates in task assignment activities where required and acts as a back-up in CDMS Manager's absence
Ability to retrieve raw datasets
Other responsibilities may be assigned as required
Serves as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of complex design, with expert clinical data delivery experience and knowledge
Reviews specification documents created by study teams, such as data transformation specifications and programming specifications
Quality assures programming outputs and support validation activities per the formal, documented QC process
Plans and works with the clinical programming group to schedule specification, programming, validation and ongoing delivery activities. Manages timelines for programming setup process, ensures issues are addressed in a timely manner to meet timelines and produces clinical data delivery validation packages for delivery to the study teams to file in the Trial Master File
Co-ordinates and manages study database updates and out of scope impacts as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
Serves on project teams to coordinate and lead development activities for multiple clinical data programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner
May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data delivery, to determine scope and limitations of the study and to discuss opportunities for innovative clinical data delivery
Trouble-shoot and solves study data delivery issues and/or external data integration issues and/or change request issues using the appropriate applications
Ensures high quality deliverables by providing senior review of study-level/program-level/multi-study core deliveries for accuracy
Participates in special projects or tasks related to the clinical data delivery as directed by the Clinical Data Delivery Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress
Attends sponsor audits and assists with in-progress audits, including presenting the Clinical Data Delivery process and procedures and pretending the validation documentation produced by the Clinical Data Service Group
To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features . Participates in Data Management department initiatives
Plan for the study clinical data delivery in detail thereby providing clarity on all aspects of the setup progress
Maintaining all necessary study documentation for the clinical data delivery
Ensures all clinical data delivery queries are responded to in a timely manner. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is perused until resolved
Contributes to training materials on a process, system or technology level. Works with ICON University and OM Management on delivery of training courses, instructor-led and on-the-job
Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and revenue allocation and forecast
Participates in task assignment activities where required and acts as a back-up in the Clinical Data Delivery Manager's absence
US/LATAM/CAN: minimum 5 years of experience in building study databases (CDMS) or clinical data programming and delivery (CDS)
EU/APAC:in depth proven experience in building study databases (CDMS) or clinical data programming and delivery (CDS)
Experience in Oracle RDC, Phase Forward Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical or CRF WorkManager required (CDMS only)
Demonstrated ability to produce CDISC and Sponsor defined clinical data deliverables (CDS only)
Experience with clinical data programming and the ability to review and evaluate clinical data (CDS only)
Extensive problem solving skills for tasks/functions related to his/her group
Strong organizational , prioritization and time management skills as to effectively organize workload and complete assignments
Ability to perform assigned tasks with little supervision
Ability to liaise professionally with team members
Extensive experience in the software development life cycle
Knowledge of database concepts
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license

Senior Clinical Quality Informaticist Resume Examples & Samples

Licensed/certified clinician preferred, with at least three years of experience in the ambulatory and/or hospital setting (e.g. RN, PharmD, EMT, MD); experience in healthcare consulting, healthcare IT, or healthcare technology preferred. Candidates with non-clinical backgrounds must possess extensive healthcare industry knowledge/expertise
Advanced degree with a healthcare industry focus preferred (e.g. MSN, MHA, MPH); equivalent degree in business, engineering, or other applicable field will be considered
Working knowledge of complex clinical data sources (e.g. claims/administrative, EMR, pharmacy, lab) and its application in healthcare software applications required. Exposure to ambulatory and/or inpatient quality measurement (e.g. NCQA HEDIS®, PQRS, NQF, NHSN, ACO) preferred
Knowledge of principles around informatics, process improvement, health services research, quality & patient safety, clinical documentation & coding, software product development & implementation, data analysis & interpretation, and/or project management a plus
The ideal candidate is collaborative and enjoys working on teams. He/she takes a proactive and creative approach to problem-solving (both internal processes and client demands). He/she demonstrates exemplary attention to detail, yet is willing and able to take a step back and examine the “big picture” when appropriate

Senior Clinical Site Monitor Resume Examples & Samples

10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV)
At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution
Extensive knowledge of ICH/FDA guidelines and thorough knowledge of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US
Thorough technical working knowledge of Remote Data Capture, EMR and computer based systems
Thorough knowledge, experience preferred, of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills
Exhibits a high level of flexibility and sets an example for adaptability for changing priorities and processes
Employs strong fiscal management of departmental budget by independently managing travel and functional expenses
Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time
Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders
Serves a role model for department through active planning, participation and representation on various projects, initiatives involving a wide breadth of internal and external stakeholders
Ability to successfully manage the designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
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Senior Clinical Site Management Coordinator Resume Examples & Samples

Assist the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating procedures
Prepare client deliverable documents using appropriate tools and draft text for straightforward documents, under guidance of senior staff
Completion of relevant Clinical Trial Management System (CTMS) fields, databasess, tracking tools, timelines and project plan with project specific information
Provide support for administrative tasks, e.g. meeting coordination, minute taking, travel arrangements, faxing, copying, couriers
Ability to work on multiple projects
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
High school diploma with 4 years’ experience in an administrative environment or equivalent combination of education, training and experience

Senior Clinical Administration Coordinator Resume Examples & Samples

Handle resolution/inquiries from members and/or providers that may include
Physician assignments
Explanation of Benefits (EOB)
Ability to navigate a PC to open applications, send emails, and conduct data entry
Experience working in a Hospital, Physician's Office, or Medical Clinical setting
Professional experience in a Clerical or Administrative Support related role
Experience working with ICD-9 and CPT Codes

Senior Clinical Program Coordinator Resume Examples & Samples

Schedules, coordinates, and plans logistics (materials, facilities, equipment, food, attendee logs, etc.) for program related appointments, meetings, events and classes using Outlook or other necessary calendar tools
5+ years of progressive administrative support experience
3+ years of experience supporting director or executive-level management
Intermediate level of Microsoft Excel experience (data entry, sorting/filtering, basic formulas and importing data to a spreadsheet)
Microsoft PowerPoint experience (creating presentations)

Senior Clinical Program Director Resume Examples & Samples

Masters Degree required
PharmD, PhD or MD preferred
Significant experience in biopharmaceutical-clinical development is required, including oversight of the planning and simultaneous management and reporting of multiple clinical studies
Experience in critical review of relevant development and regulatory documents outside the clinical arena required

Senior Clinical Trial Leader Resume Examples & Samples

Serve as a Senior Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
Solves problems with support from Clinical Management arising during clinical study execution, and will seek guidance for more complex problems, as needed
Track assigned projects budgets to ensure adherence to business plans
Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
May lead several small/medium clinical trials (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve other clinical operations staff
BS, MS, PhD preferred
Medical device experience a plus

Senior Clinical Imaging Specialist Resume Examples & Samples

Call on new and existing accounts to identify and create opportunities by establishing creditability, assessing customer needs, and providing solutions/recommendations via the sale of Bayer Medical products and services
Promote and train to the proper safe and effective use of products
Work closely with the Sales and Service Representatives to understand client needs and changes
Build and maintain effective relationships with Bayer Medical Dealers, and OEM’s as appropriate
Follows clinical processes
Consistently perform above the national average with customer satisfaction results
Promote all Bayer Medical projects and programs in an effective and consistent manner
Maintain database of accounts in a proactive, accurate and timely manner
Prepare and submit reports in a proactive, accurate and timely manner
Manage field expenses and evaluate profit margin in a proactive, accurate and timely manner
Consistently get paperwork in on time, and Meets deadlines
Remain current on new technologies and the medical device industry
Keep current with any registered technologist licenses
Support territory management in team leadership activities and achievement of broader territory objectives
High level of technical competency
Active in promotional programs
This position will involve up to 50-65% overnight travel based on home base location

Senior Clinical Site Monitor Resume Examples & Samples

10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV, DMD, CRO partnership)
Mastery of all site monitoring visits (pre-post) while also understanding that site personnel may require support until lock
Ability to manage successfully with designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
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Senior Clinical Site Monitor Resume Examples & Samples

10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials specifically oncology trials as well as across the development spectrum (phase I-IV)
Ability to manage successfully with designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items, make appropriate decisions as well as action plans
Effective communication skills (emotional intelligence, verbal cues, non-verbal cues, adapting for audience, and listening to create openness and trust)
1604818

Senior Clinical Trial Operations Manager Resume Examples & Samples

Bachelor's degree (advanced degree preferred) plus at least 10 years of experience in pharmaceutical industry or clinical-related discipline including at least 8 years clinical research experience. 2+ years of prior management and/or supervisory experience in coordinating international clinical trials is required
Strong interpersonal and communication skills (verbal and written) - Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills
Ability to work autonomously and to efficiently & effectively provide status reports
Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.)
Ability to work in an international environment with internal and/or external partners (CROs)
Strong English skills (verbal and written if English is the second language)
Ability to adapt and be flexible to change and managing internal and external impediments
Knowledge or ability to rapidly gain knowledge with programming/query languages
Knowledge of industry Data Management standards and practices

Senior Clinical Program Leader Resume Examples & Samples

Contributes to the development of the target product profiles, CDPs including scenario planning, high-level forecasting of timelines, assesses program level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies. Handles unique challenges and decisions that have an impact on function and disease area. Communicates initial budget, resource, risks and timelines to review bodies, and subsequent changes, as appropriate
Accountable for meeting all operational deliverables in accordance with the timeline, cost and quality commitments. Maintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program and ensures alignment of operational program to the development team’s goals
Operates at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise. Long-range Planning horizon is typically 1-3 years
Serves as a primary consultant to senior-level colleagues (eg, Clinical Sub-Team Leaders, Development Sub-Team Leaders, Project Team Leaders, Group Medical Directors and Development Review Committee Chairs), functional leadership and cross-functional stakeholders within and outside of gRED. Work is performed in partnership with, but without appreciable direction from Program Group Leader
For molecules that are at the Life Cycle Investment Point stage, the Sr CPL partners with the PDG Clinical Operations colleagues to contribute to strategic input, alignment and successful transition of the molecule to Late Stage Development
Creates an environment supportive of innovation and smart risk-taking to drive and implement novel approaches to drug development
Provides program leadership to the gRED Clinical Operations study teams with program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results
Mentors and coaches staff (direct and dotted-line reports). Provides timely feedback to functional managers regarding staffing needs and individual performance in the program
Provides coaching, mentoring, performance and talent management, and succession planning. Identifies, recruits, hires, and develops Clinical Operations staff, as well as oversees their work to ensure all department goals, deliverables, and objectives are met
Ensures that employees are appropriately trained and comply with company and regulatory standards
Creates a positive work environment by encouraging mutual respect, innovation and accountability. Creates and maintains Clinical Operations as a ‘great place to work&#8217
Resources projects to enable teams to meet deliverables
Actively participates and contributes to governance (eg, gPRC, DRC) and CPL leadership forums
Sponsors, leads and/or participates in critical department or broad organizational, cross-functional initiatives
Fosters a continuous improvement mindset by partnering to optimize processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs
Serves as Business Process Owner and oversees Subject Matter Experts as nominated
Leads and supports staff through organizational change and growth and provides input to senior management on potential organizational changes and improvements
Creates an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel

Senior Clinical Study Assoc Resume Examples & Samples

4 years with Associate/nursing degree, or 2 year with BS
Phase II/III Oncology trial experience strongly preferred
Global trial experience strongly preferred

Senior Clinical Evaluation Report Spec Resume Examples & Samples

Medical device experience
4+ Years clinical research experience with Bachelors or 2+ Years with advanced degree
Masters or PhD degree(s) in biomedical sciences or technical disciplines
Medical device industry experience or related industry experience
Scientific knowledge in cardiovascular physiology and cardiac arrhythmias
Proficient knowledge of medical terminology, clinical research study processes, basic statistical concepts, demonstrated ability to incorporate and adhere to regulatory standards
Proficient knowledge of physiology and/or applicable disease states, AF therapies and technologies
Possess strong understanding of study design, metrics and medical writing
Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing
Process improvement capability

Senior Clinical Quality Spec-audit Resume Examples & Samples

7+ years experience (or 5+ years with a M.S. degree) directly supporting clinical research within a regulated environment, or other relevant quality experience in a regulated environment
Experience with FDA and international regulations (pharmaceutical and/or device, e.g., 21 CFR 812, 50, 54, 56, 820, ISO 13485, ISO 14155) and/or experience in Quality System regulations
Knowledge of 21 CFR 803, 806, ISO 14971

Senior Clinical Program Coordinator Resume Examples & Samples

Licensure as a Registered Nurse by Board of Nurse Examiners for the State of Texas with a minimum of a Bachelor's of Science in Nursing; Master's degree preferred
PharmD with licensure in the State of Texas
LMSW with licensure in the State of Texas

Senior Clinical Program Coordinator Resume Examples & Samples

Facilitates care of new patients in clinic by ensuring patients are scheduled in timely fashion at specialty clinics and that necessary clinical data is available to consultant
Records patients' medical history and may use questionnaire to determine appropriateness of exams
Reviews and educates patients on procedures, preparation instructions and answers patient's questions concerning medical exam
Responsible for meeting with patients and provider to discuss plan of care before patient is discharged
Aids transfer of information between clinic and university affiliated hospitals by ensuring all relevant clinical data is available to admitting physicians. This may include the current medication list, problem list and pertinent study results
Notifies care providers of patient admission and/or exam results
Ensures follow-up appointments and tests/procedures are scheduled for patients
If applicable, ensures discharge medications are entered into system and/or verifies home health orders, durable supplies and PT orders are placed
Functions as liaison with other departments concerning coordination of multiple and/or special procedures
Collaborates with management to implement new, or modify existing, processes regarding: patient scheduling, patient exam preparation information, location of equipment, and communication of exam results
Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records

Senior Clinical Supplies Manager Resume Examples & Samples

Review protocols and designs appropriate supply chain strategy
Create and revise Standard Operating Procedures as required
Design specifications for automated randomization and drug supply management systems
Oversee a variety of logistics issues, including but are not limited to supply chain services, inventory control, import-export, shipment of products and third party warehousing
Identify key stakeholders within CMC and clinical project teams to ensure on time availability of drug supplies
Lead process improvement efforts and may develop specific department plans and procedures

Senior Clinical Adminstrative Coordinator Resume Examples & Samples

Perform as a SME (Subject Matter Expert)
Entering notifications and Providers' status of an existing inquiry, and determining if follow up is required
Provide excellent Customer Service to both Providers and members
Constantly meet established productivity, schedule adherence, and quality standards while maintaining good attendance
Must be able to work Monday – Friday 8:30am – 5:00pm, with flexible schedule as needed
Beginner experience in using Microsoft Windows based PC software (this includes Word, Excel, and Outlook creating, saving, editing documents, spreadsheets, and email usage)
Understanding of HIPAA Regulations
Professional experience with Medical Terminology
Ability to multitask in a face pace work environment

Senior Clinical Transformation Consultant Resume Examples & Samples

Accountable for successful deployment of UHC’s Clinical Support program at the practice level, including but not limited to, introducing and educating practices on the value/use of reporting tools and delivery of reports via UHC’s Physician Portal
Consults and partners with internal UHC matrix partners and the practice to identify organizational and structural challenges hindering achievement of desired program outcomes
Monitors monthly and quarterly performance reports of assigned practices
Work with the practice and Optum to align and integrate Optum care/disease management programs and population health services to augment the practice’s capabilities, support their care management efforts and add value to the patient care experience
5+ years of experience in at least one of the following: quality improvement, practice management, medical management, health care analytics, managed care contracting OR experience in a primary care or multi-specialty practice that has successfully implemented PCMH, ACO programs or quality improvement initiatives
Clinical quality improvement experience
Population Health (PCMH) experience

Senior Clinical Program Resume Examples & Samples

As Clinical Program - Lead Heart Failure, you have the medical co-responsibility for a Heart Failure phase III program with the overall aim to achieve registration
You steer the co-development and the review of study- and project-related submission documents
In your new role you continuously monitor the products' efficacy and safety
You analyze, prepare and review presentations on trial results, as well as scientific statements
Furthermore, you ensure the collaboration with Drug Safety, Clinical Operations, Data Management / Statistics and business functions like Marketing and Market Access
Also, you co-chair an international medical sub-team (with up to 20 members in a matrix environment)

Senior Clinical Innovator Resume Examples & Samples

Leverage clinical experience to identify new innovative product concepts and designs
Review concepts and prototypes for clinical feasibility
Support Development teams with clinical expertise
Establish and maintain strategic partnerships with acute and primary care facilities local to Skaneateles to gather
Bachelor of Science in Nursing, Engineering or related field required
5 years' relevant clinical experience in Med-Surg and ICU (Desired)
Strong understanding of Good Clinical Practices (GCP)
Proficiency in research including IRB, data collection, consents and research analysis
Knowledge of standards testing for diagnostic medical devices highly desirable
Strong communication and collaboration skills
Knowledge of standards testing for diagnostic medical devices
Therapeutic expertise in knowledge of sensor technology
Ability to perform literature reviews
Experience with ethnography

Senior Clinical Affairs Specialist Resume Examples & Samples

Bachelor's degree in the fields of Healthcare Sciences plus minimum 3 years of working experience and in which at least 2 year Clinical Trial relevant working experience
Knowledge of GCP and understanding of national regulations essential
Good self-motivation and self-organization
Good interpersonal skills, diplomacy and the ability to motivate and organize other
Fluency in both verbal and written English essential
Computer literacy essential
30-50% travel required

Senior Clinical Workflow Consultant Resume Examples & Samples

Provide clinical consulting support throughout the customer project lifecycle including pre-sales demonstrations, solution design workshops, customer workflow analysis and mapping, user training, go-live support, and post-implementation consulting
Provides clinical consultative support to customers during implementation, immediately post-implementation, and into project maturity working with customers on analysis and solution enhancement
Research, design, and implement comprehensive workflow and clinical consultative programs in direct support of the Patient Flow solution
Perform content needs analysis with SH solution managers, customers and other subject matter experts to design and develop the Practice tool kit: project templates, checklists, workflow diagrams, and other tools as needed
Become the go-to expert in the functional use of Patient Flow and MobileView Analytics (MVA)
Provides clinical consultation and support to internal teams involved in product development, ensuring that clients’ needs are accurately represented in product planning cycles
Consults with and serves as an interface with Sales, PSO, Product Development Teams, and appropriate other areas to ensure continuity in systems planning, development and implementation
Performs comprehensive post go-live project assessments to ensure customers are maximizing the use of Patient Flow and MVA
Develops Case Studies and whitepapers that describe the business case or ‘return on investment’ that Patient Flow brings SH customers and to the broader marketplace
Mentors newer members of the Workflow Consulting Practice to help ensure their knowledge and skill levels are sufficient to be successful in their role
Participates, as a subject matter expert, in completion of RFIs and RFPs
Ability to travel up to 75% required
Bachelor’s Degree in Nursing required, Master’s Degree preferred
5 years clinical experience in an acute care setting
5 years experience as a Consultant in healthcare
Experience with clinical workflow analysis required. Patient flow analytics a plus
Experience with healthcare technologies, such as patient flow monitoring, patient security systems, falls risk management tools, pagers and wireless communications devices desired
Demonstrated ability to align clinical practices and understanding of products into a customized, consultative program for healthcare customers
Extensive knowledge of current medical information technology and applications required
Demonstrates superior written and verbal interpersonal communication skills
Effectively communicates the capabilities and limitations of the technology to work collaboratively with technical personnel, clinical staff, consultants, vendors, and senior staff
Ability to establish priorities, work independently, and proceed with objectives without supervision
Solid history of establishing and meeting work schedules with limited time frames and under tight deadlines
Extensive knowledge and proficiency in MS-Office products - Word, Excel, Visio, PowerPoint, and Outlook, required
Proficient in virtual meeting tools such as GoToMeeting, Live Meeting
Knowledge of database structures a plus
Knowledge of business intelligence technology, and Tableau specifically, a strong plus
Experience with clinical workflow transformation and transformative technologies
Specific experience with Patient Flow technology desired
Clinical experience in OR, ED a plus
Experience with EMR technology desired
Knowledge of LEAN principles

Senior Clinical Process Analyst Resume Examples & Samples

Works closely with the Manager of Clinical Informatics Process Lead and peers to provide core system expertise and assistance as needed to successfully implement and support patient data automation and work through the system life cycle
Assists with change management efforts around the implementation of the clinical informatics software through the execution of change management / enhancement processes
Assists with the implementation of the clinical informatics software to enable the process of care in hospitals
Assists with monitoring new system setup and training to ensure adherence with enterprise-wide operational, regulatory, and clinical process guidelines
Assists with the definition of content, build, and training needs for system enhancements related to CPOE, clinician documentation, and quality/patient safety initiatives
Provides hands on assistance and support of facilities in all phases of initiatives such as CPOE, BCMA, Physician documentation, etc
Engages with hospitals as they prepare for implementation of CPOE / Physician Documentation / MU requirements to ensure the processes and system functionality are working effectively and/or to identify areas that require refinement

Senior Clinical Territory Account Manager Resume Examples & Samples

Adoption and use of Illumina products
Product and technology development and optimization
Develop high-value, long-term profitable customer accounts through relationship building sales techniques
Satisfy all product and technology training requirements as established by Sales management and the Training department
Act as a central communication point to ensure information flow on all aspects of the business relationship is efficient, effective, and deployed appropriately
Build relationships at all levels of the customer organization. Facilitate communication and relationship building between Illumina and client executives
Lead the account team to plan and organize activities to ensure efficient and effective sales support, field service, and technical and applications support are provided
Participate in the introduction of new technology platforms and products to key accounts. Facilitate and enable flow of information to and from customer during pre-commercial phases
Understand the competitive dynamics within the account and lead development and implementation of strategies and tactics that best position Illumina technology and products to neutralize competitor growth
Provide Illumina management with regular feedback on account status and key initiatives

Senior Clinical Portfolio Specialist Resume Examples & Samples

Manage Clinical Trial Management System (CTMS) data entry and regulatory document management lifecycle of Trial Master File (TMF) study documents at the country, site and patient level with strict adherence to ICH, GCP and FDA regulations as applicable
As knowledge expert of data and systems, provide support to both the Field Monitoring and Project Management Organizations, pertinent to the administration of CTMS and TMF data, quality, distribution and reporting. Such as
Provide trial site setup and personnel updates in global clinical planning and tracking database (ClinAdmin)
Track screening activities, create and maintain the Master Investigator lists for all clinical trials during the entire site selection and approval process
Generate performance metrics for potential Investigators and study start up average time for sites
Provide ClinAdmin support for Clinical Research Associates, Regional Associate Directors, and Project Managers to address questions/problems on host system
Run reports on a regular basis; analyzing and solving issues that would prevent timely roll-up of milestone event dates for the US
Assist in maintaining TMF (hard and electronic versions), Safety Notifications, Amendments and site personnel contact information within the scope of processing/scanning, quality review and compliance, archiving and tracking. Raise alerts where current status of data quality or performance is at risk to noncompliance
Assist in managing the quality and compliance of CTMS and TMF through use of reports/tools including CREDI, SharePoint, CTMS, site nomination tools, performance metric tool, and dashboards. Perform periodic regulatory document QC and reconciliation activities of CREDI, to ensure document quality (legibility, naming conventions etc.) standards are maintained for Novartis eTMF documents
Serve as the primary point of contact/liaison with Field Monitoring Operations, and global Drug Regulatory Affairs (DRA); pertinent to the administration of VDR/RDR and eTMF setup during study start-up and changes to Principal Investigator or 1572
Support production of comprehensive business reports, data extracts and tools to improve and maintain CTMS data quality and operations performance utilizing Excel, PowerPoint, graphing and systems skills
Support IT and web-based system (SharePoint) projects around automation of reports or development of tools to aid/drive process improvement as appropriate
Perform extra assignments beyond assigned regular responsibilities as assigned by Manager

Senior Clinical Quality Associate Resume Examples & Samples

Cooperation/Teamwork: team player with autonomy capable of working independently under minimal supervision
Planning and organizational skills: Organizes self in an efficient manner
Problem solving: gathers information before making decisions; weighs alternatives against objectives and arrives at reasonable decisions
Adaptability: remains open-minded; performs a wide variety of tasks and changes focus quickly as demands change

Senior Clinical Team Lead-work From Home Resume Examples & Samples

Knowledge of ICH Guidelines, Good Clinical Practices, and FDA regulations
Strong understanding of clinical trials, study design, and drug/device development process
Knowledge of scientific, medical, and regulatory terms
Excellent professional writing and communication skills
Strong computer sills with demonstrated ability using clinical trial databases, electronic data capture, proficient in Microsoft Office software, including Work, Excel, and PowerPoint, and ability to learn new software, if required
Demonstrated leadership and/or mentoring skills
Demonstrated training skills
Excellent organizational and prioritizing capabilities
Resource with heightened analytical abilities and problem solving in a fast paced environment
Excellent interpersonal skills, detail-oriented, and meticulous
Ability to manage, organize, and make decisions
3-5 years experience as a Sr. CRA, Clinical Team Lead, or equivalent role
3+ years direct oncology experience in Phases l – lll
Prior experience mentoring and/or training less senior team members
At least five years direct oncology experience in Phase l – lll
Three or more years of experience in a Sr. CRA, Clinical Team Lead, or equivalent role
Experience managing study timelines, deliverables, and/or vendors

Senior Clinical Program Consultant Resume Examples & Samples

Provide leadership for innovation and change in our work and processes
Work across all UM functional areas: OptumRX, United Clinical Services, Behavioral Health Options, Dental/Vision, and Harken Operations to align process, track oversee volumes and turn times
Manage and Monitor regulatory turn around times
Update regulatory requirements as states and federal government change them
Update approval and denial letters based on changing state and federal requirements
Routinely provide QA for UM Intake administrative approval letters
Support audit preparation and participation
Manage, implement and assure NCQA requirements are met for UM standards
Business owner for end to end process, including Policies, Standard Operating procedures and assure desk level procedures align across all functional areas
Owner of Harken Medical Policy Tool
Licensed Registered Nurse required
3+ years of experience in health care setting, ACO, Hospital, Clinics, systems required
3+ years of experience working with a UM program for health insurer required
3+ years project management or project lead experience managing multiple teams required
3+ years of experience in data analysis
Advanced proficiency in MS Office (Excel, Access and PowerPoint)
Travel within MN 25-50% of the time
3+ years of experience with system configuration and or testing

Senior Clinical Trials Accountant Resume Examples & Samples

Develop solid understanding of Company’s ongoing and future clinical trials, including CRO, site and database contracts, budget and payment plan relationships, and general understanding for rationale for clinical trial
Build and maintain solid relationships with clinical team. Operate as a business partner to clinical team
Participate in meetings with project management, clinical trial team, CRO, sites and database providers to understand trial status, issues, questions and upcoming milestones
Obtain supporting documentation and in concert with Company’s clinical accrual policy, including recording timely, accurate and complete accounting entries for prepaids and accruals and prepare associated reconciliations
Provide both historical and forecasted financial information to FP&A, executive management and clinical trial management
Maintain and update existing clinical accounting policies and procedures. Ensure key stakeholders understand and buy-into revisions. Educate stakeholders and employee base as necessary
Interface and support external auditors, internal controls and audit teams, FP&A and executive management
Bachelor’s degree in Accounting or equivalent with a minimum of 5 years’ experience
CPA with at least three years of recent Big Four experience, preferred
Must be a self-starter
In-depth knowledge of US GAAP and clinical trial accounting
Proficient with Microsoft Excel, Word & Outlook; Oracle and Hyperion experience a plus
Requires flexibility to put in extra hours during critical times such as month, quarter and year-end close cycles
Strong attention to detail and highly organized
Ability to gather, analyze and interpret information for completeness and accuracy; capable of identifying problems, researching and recommending resolutions

Senior Clinical Program Coordinator Resume Examples & Samples

Licensure as Registered Nurse by Board of Nurse Examiners for the State of Texas with a minimum of a Bachelors of Science in Nursing, Master's degree preferred. - PharmD with licensure in the State of Texas.- LMSW or LCSW with licensure in the State of Texas. At least five (5) years of related clinical experience required with past experience in program development and / or management preferred. BLS certification required. Knowledge of Microsoft Excel, Word, Outlook, Power Point required; knowledge of Microsoft Visio and Project preferred
Functions as liaison with other departments concerning coordination of disease management and care coordination initiatives across the health system
Collaborates with management to implement new, or modify existing, policies and procedures, as needed
Leads efforts in quality reporting and effectiveness monitoring of programs under management

Senior Clinical Bioinformatics Expert Resume Examples & Samples

Ensuring the best use of clinical genomics data in all therapeutic areas of Boehringer Ingelheim
Application of sophisticated computational biology tools/databases to analyze complex biological data as well as large scale multi-omics data, in particular from next generation sequencing and microarrays
Collaboration with external partners, contract research organizations (CROs), academic institutions and consortia
Within a regulated environment, support of development, implementation and use of software tools, databases and technologies
Ensuring the apporpriate quality standards (e.g. GCP)

Senior Clinical Value & Outcomes Liaison West Region Resume Examples & Samples

Demonstrated technical and scientific expertise in Oncology/Hematology is strongly preferred
An additional degree in health economics, health outcomes, health policy or public health a plus
Field based medical experience in the pharmaceutical industry preferred
Thorough knowledge of managed care, pharmacoeconomics, disease management, and medical research
Excellent interpersonal, communication, and presentation skills are required (including ability to network), strong personal integrity; teamwork abilities and a customer focus sense of urgency are necessary
Must have the ability and knowledge to effectively communicate critical medical, scientific and business information to internal stakeholders as well as customers in the medical community
Excellent interpersonal communication and presentation skills
Must possess a thorough understanding of the FDA, OIG, HIPPA and other ethical guidelines relevant to the pharmaceutical industry to ensure compliance with these external standard operating procedures
Strong working knowledge of the organization of Microsoft Office Suite (Word, PowerPoint, Excel, Access)
Must be able to organize, prioritize, and work effectively in constantly changing environment
Strong working knowledge of the entire Microsoft Office Suite (Word, PowerPoint, Excel)
This is a field based position with field based priorities
Extensive travel (approx. 50-70%) is required with this position
Geographic location is flexible based but must reside within geography

Senior, Clinical Pharmacokineticist Resume Examples & Samples

Executes clinical Pharmacokinetics/Pharmacodynamics (PK/PD) research or development that achieves project and therapeutic area goals. Understands PK/PD regulatory advances, strengths, weaknesses, opportunities, and threats and assists with responses and appropriate new strategies
Utilizes PK/PD expertise to provide PK/PD consultation to the business and leadership on decisions and development plans for multiple projects within a therapeutic area
Develop productive collaborations and communications with other groups across multiple disciplines
Writes, communicates, presents PK/PD materials
Primary contributor to PK/PD interpretations of reports for regulatory filings and clinical protocols

Senior Clinical Pharmacologist Resume Examples & Samples

Demonstrates an understanding of 1) PK/PD principles, physiology, pharmacology and pathology; 2) operational and scientific aspects of early development studies; and 3) quantitative analysis
Ability to generate development strategies, design clinical pharmacology studies and analyze PK/PD data utilizing sound scientific principles. Ability to relate clinical pharmacology to the broader development paradigm
Understanding and ability to apply appropriate regulatory and ICH guidelines in the design, analysis and interpretation of clinical pharmacology studies
Excellent oral and written communication skills for effective interactions in various environments including, but not limited to multidisciplinary teams, regulatory agencies, scientific symposia, advisory boards

Senior Clinical Quality Auditor Resume Examples & Samples

Bachelor’s degree in a life science area
Strong experience in GCP audits in a pharmaceutical or CRO environment
Thorough knowledge and understanding of GCP regulations and Guidelines
Above average negotiation and conflict management skills
Proven flexibility and ability to adapt quickly to shifting priorities and workload

Senior Clinical Data Coord Resume Examples & Samples

Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff (excludes
Manage delivery of projects through full data management study life-cycle (with minimal guidance)
With guidance from DTL or Manager, manage project timelines and quality; determine resource needs; identify out-ofscope
Bachelor's degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing

Senior Clinical Engineer Resume Examples & Samples

Associate's degree in Biomedical Equipment Technology, or Biomedical Equipment Technician Training in US Armed Forces the equivalent of Computer Information Systems, Management Information Systems, Information Systems, Computer Science, Engineering or Bachelor's degree (or the equivalent) with experience in the biomedical field
Ability to relocate to Columbia, MO
Ability to learn and apply new technical skills and concepts quickly
Intermediate computer skills, including Microsoft Office suit
Ability to lift 50-75 lbs
Imaging equipment experience Intermediate networking knowledge Biomedical Certification (AAMI CBET) Hospital environment experience

Senior Clinical Affairs Resume Examples & Samples

Conducts audits independently and act as lead when multiple auditors present
Prepares and maintains a Division audit schedule for GCP activities; reviews and agrees to site audit schedules; plans; observations and ratings
Monitor and analyze both internal and external audit outcomes and react/direct/manage as appropriate
Participates in site-led audits of the site’s quality system; called upon as an SME during CRQS audits/regulatory inspections as well as perform activities such as scribe and/or document reviewer
Preparation of reports to Senior Management documenting audit activities; metrics; findings and resolutions and raise significant issues of noncompliance. Manage post-audit activities and follow-up on any necessary corrective and preventive actions and resolve any conflicts
Manage and maintain files and documentation associated with all audit activities
6-8 years Quality Assurance or experience within a clinical research organization including 3-4 years QA auditing experience, GCP auditing experience and ASQ CQA Certification/Lead Audit Certification/training is preferred

Senior Clinical Trial Leader Resume Examples & Samples

Project management skills with the ability to handle multiple projects is required
Leadership skills in a professional ethical manner are required
Technical writing skills are required
Experience with clinical trial monitoring with the ability to oversee monitoring activities is preferred
Experience within a Medical Device, Pharmaceutical or Contract Research Organization is required
Experience within the cardiovascular industry is preferred
Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE)

Senior Clinical R&D Consultant Resume Examples & Samples

A client facing role defining Clinical and Pharma R&D solutions and be a trusted advisor for our Life Sciences clients
Contribute to the design and execution of our Clinical R&D Development projects
Lead/advise our functional, business analysis and delivery teams with your expertise in clinical data management and clinical trial systems, processes and tools
Provide project/program management oversight when necessary ensuring projects are delivered on time and within budget
Sell and deliver new opportunities with existing and new clients in the area of Pharma R&D and Clinical development
Provide on-going business development to achieve targets and goals to grow and expand our offerings within the Life Sciences industry
Skill development: helping our employees grow their foundational skills
Finding the dream job at IBM: navigating our company with the potential for many careers by channeling an employee’s strengths and career aspirations
Diversity of people: Diversity of thought driving collective innovation
Http://www.ibm.com/ibm/responsibility/initiatives.html
Http://www.ibm.com/ibm/responsibility/corporateservicecorps
At least 7 years of experience in the Life Sciences Industry in the Pharma R&D area
At least 10 years delivering managing and selling IT projects with through understanding of CSV & Part-11
At least 5 years of experience and expertise in clinical data management, clinical trial systems and processes and tools including Oracle Clinical, Medidata, etc
At least 3 years of experience with functional design and working with global development teams Understanding of CDISC standards
Understanding of CDISC standard

Senior Clinical Coverage Analysis Specialist Resume Examples & Samples

Effective time management to meet deadlines
Conducting Quality Assurance (QA) reviews of Coverage Analyses (CA’s) completed by CAS-I’s
As needed, developing CA’s as outlined within the CAS-I role, and seeing the entire analysis process through to completion to ensure client deadlines are met
Daily reporting on work planned and completed, both individually and client-specific
Interacting with clients on a weekly basis to provide status updates and collect new processing information for dissemination to the Research Office team
Assisting with internal team development via training, updates to tools and techniques, and providing general mentorship
Certification in Healthcare Research Compliance
Successful past experience supervising, mentoring and training others
Experience in coding or billing healthcare claims
Experience in healthcare compliance, general healthcare billing compliance, research billing, or research billing compliance a significant plus
General knowledge of federal regulations related to clinical research and billing compliance
Working knowledge and experience with clinical trial regulatory documents such as protocols, informed consent documents and Clinical Trial Agreements (CTA)
Experience working in an administrative/ business office of a university, hospital, or research institute

Senior Clinical Engineer Resume Examples & Samples

Project management including protocol design, investigator contact, CRO selection & management
Investigator’s meeting organization, working with CRO to do site qualification visit, site initiation visit, monitoring visit and close out visit to make sure the clinical activities compliant with GCP, applicable local law and SOPs
Coordination with medical team, marketing/business team and regulatory team to make the project going forward
Provides clinical support to new product development
Other clinical associated work
Medical background
5 years of experience of clinical operations, medical device field preferred
Fluent spoken English and written English
Team worker with good communication skills

Senior Clinical Trial Operations Manager Resume Examples & Samples

Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility; Definition of the Case Report Form content and testing of the end product. Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing) and completion guidelines, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the CTT. Review other CTT and vendor-developed or co-developed documents (e.g. specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality)
Ensure proper overview and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures. Perform patient data validation homogeneously and fulfilling required quality standard. Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required
Coordinate and support field-monitoring activities through regular meetings: teleconferences and/or visits to CSU’s, training of monitoring teams, investigator meetings. CRO management if applicable. Prepare and lead data review meeting, organize and contribute to medical review meetings
Collect, synthesize and report study information. Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner
Investigational Product (IP) Management. Collaborate with the CSP to validate IP needs, specifications, packaging, shipment (including resupply) and reconciliation process
Preparation and oversight of study audits/inspections both internal and external
Provide oversight and preparation for FDA pre-approval inspections (PAI)
Mentors/trains new comers - Participate, as a delegate to TL, to the training of new CTOMs on therapeutic area and general responsibilities within their function
The Dedicated Project Expert (DPE) is accountable for operational oversight of the clinical program conducted within Trial Operations. He/she coordinates with CTM(s), SDM(s) and CTOM(s) working on the designated program to ensure operational consistency, to identify possible synergies, and to ensure that the team works closely together to meet the program goals on time and with good quality. The DPE assists the CSO CSP Project Leader (PL) in developing/ following the execution of the program operational statement. The DPE is the primary point of contact for PL within TO and will represent CTMs/SDMs/CTOMs working on program as the designated CSO CSP Project Team Member. He/she is the primary responsible person for escalation of program issues/information within Trial Operations and will ensure that PL and TL are being provided with regular reporting on the program progress. The DPE provides input to help TL ensure alignment according to risk adjustment and study milestones
Minimum 10 years of experience in pharmaceutical industry or clinical-related discipline including at least 8 years clinical research experience
2+ years of prior management and/or supervisory experience in coordinating international clinical trials
Ability to handle multiple task and to prioritize, strong organizational and presentation skills
Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc)
Ability to work in an international environment with internal and/or external partners (CROs, …)
Advance Degree in scientific discipline

Senior Clinical Admin Coordinator Resume Examples & Samples

Manage the intake of members or the admission and discharge information post notification
Work with hospitals, clinics, facilities and the clinical team to manage request for services from members and providers
Provide appropriate triage and care coordination notification cases for non - clinical assessment/intervention
Assist the clinical staff with setting up documents and triage cases for clinical coverage review
Handle resolution and inquiries from members and/or providers that may include
Experience working within the healthcare Industry
Experience working with Medicare and/or Medicaid Services

Senior Clinical Pharmacokineticist Resume Examples & Samples

Responsible for providing clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, including PKPD studies, analysis of data using complex PKPD modelling and simulation methodologies, development and delivery of regulatory strategy (e.g IB/IND, end of phase 2, and BLA) etc, and data analysis and reporting of clinical studies
Function as the sole point of contact for all CPD activities on projects at all stages of discovery and development and be able to influence team strategy using modelling expertise
Be pivotally involved in assessing and managing analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to the Company's clinical development teams
Drive clin pharm regulatory strategy for projects at all stages -- IND to BLA -- and defend strategy at regulatory meetings
Help design and conduct translational PK/PD modelling and simulation to support drug design goals, designs of PK/PD and safety assessment studies, and dosing justifications for first-in-human clinical studies
Collaborate with toxicologists on the design, monitoring, and reporting of nonclinical safety studies; prepare TK subreports; comply with good laboratory practice (GLP) regulations for GLP studies. Perform PK analyses for GLP studies per SOPs, record data and analysis results in GLP-compliant manner, ensure timely and clear communication with GLP SD/PI on GLP studies, and contribute to GLP study reports
Mentor other junior PK scientist’s staff on clinical pharm science and strategy
Strong publication and conference presentation track-record required
Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc) is highly desirable
Knowledge of bioanalytical expertise, especially of biologics is desirable

Senior Clinical Trial Leader, Early Phase Resume Examples & Samples

Clinical Scientist for Phase I/II including multi-country / multi-center trials. The main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration
May support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc
Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
Contribute to the evaluation of clinical sites and external service providers for performing TM studies in healthy volunteers and patients
Provide expert advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned
Identify and help implement areas for process improvements
Contribute to talent and career development of CS&I and TM staff through active participation in on-boarding, training and mentoring activities of new CS&I or TM hires. In collaboration with CS&I management, contribute to the hiring/interview process for new CS&I or TM hires
Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTAs and Clinical Scientists

Senior Clinical Oncology Sys Ana Resume Examples & Samples

Experience Training all levels of staff on OIS systems
Ability to work closely with vendors to ensure clinical uptime for all clinical systems
Solid understanding of Windows OS and Networking Concepts
MS Visio experience
Solid foundation on computer hardware
Base understanding of virtual compute environments

Senior Clinical Management Associate Resume Examples & Samples

30% [Performance Analysis]
Design, manage, and execute client diagnostics, operational assessments, and strategic recommendations to drive ROI for our Population Health clients
Analyze and interpret client specific data as well as aggregate data across our network to measure utilization, productivity, cost, health outcomes, risk factors, and interventions to improve clinical pathways
Monitor and track over time the performance of clients using Population Health tools
Ensure client & athenahealth are meeting all agreed upon performance deadlines and milestones
Work cross functionally with internal athenahealth teams to ensure successful client performance management experience
Support product team on a consultative basis to provide clinical guidance on functionality that supports or enables best practices developed by the Performance Management team
Build strong relationships with client stakeholders
40% [Support Workflow Development and Client Configuration]
Assess client needs, and share best practice related documents with the client during the workflow development process
Clinical background required (RN, PA, FNP, or other mid-level healthcare degree, or higher)
Must have a minimum of 3+ years in a clinical setting experience required
Experience designing and implementing clinical workflows to optimize best practices
Experience working with cross-functional groups and teams to achieve common goals
Ability to complete projects with tight deadlines and time constraints
Proficiency in Microsoft Office Suite: Excel, PowerPoint, Word, Outlook, Visio, OneNote
Proficiency in additional support tools: WebEx, SharePoint, Salesforce

Senior Clinical Product Manager Resume Examples & Samples

Participate and contribute in cross-functional core teams consisting of marketing, engineering, systems integration, operational readiness and documentation
Maintain awareness of new and emerging technologies and the potential application with Beta Partners
Solicit, coordinate and document internal and external customer feedback for assigned products. (Definition Phase, Development Phase, and Validation Phase)
Create and execute project work plans and revise as appropriate to meet changing needs and validate requirements
Identify resources needed and assign individual responsibilities with cross functional team members during the product development phases
Manage day-to-day operational aspects of a project and scope
Provide standard reporting metrics to team manager
Gauge, report and mitigate the negative exposure and/or risk during a project
Continually seek opportunities to increase customer satisfaction and deepen customer relationships
Manage day-to-day internal and external customer interactions
Manage client expectations to ensure alignment with the overall project/program objectives
Develop lasting relationships with customers (“Trusted Advisor.”)
Communicate effectively with clients to discern the problems that they are experiencing and assist with determining root cause
Provide an evaluation of the root cause to development team for further investigation and prioritization
Engage with the operational readiness team and provide as needed training
Support reviewing and editing documentation manuals for implementation procedures and include lessons learned during alpha/beta validation period
Maintain are repository consisting of customer's pharmacy business objectives, and medication use process
Excellent interpersonal communication skills with the ability to work well with customers and with employees at various levels
Experience in the operation of decentralized and/or centralized pharmacy automation equipment and software
Strong troubleshooting and problem-solving skills essential coupled with a results-orientation and a bias for action
The successful candidate must be self-motivated and be able to work autonomously
The successful candidate will be comfortable living with a reality of being unable to meet the requests of all stakeholders and must be able to manage and direct from a position of non-authority
B.S. in Pharmacy, Pharm.D, or B.S. in Nursing or B.S./B.A. in Business; Masters Degree desirable
5+ years of experience in a management position at a health system pharmacy or nursing department
3+ years of experience in complex project management
3+ years of experience with hospital materials management and/or information systems
Demonstrable knowledge and understanding of Omnicell products and solutions
Demonstrable knowledge and understanding of the agile development process
Demonstrable knowledge of Team Foundation Server, Microsoft Project & Excel

Senior Clinical Analytics Analyst Resume Examples & Samples

Consults with end users to define project/report requirements
Develops databases to collect and analyze information and generates reports from multiple data sources, systems and applications
Provides educational, technical and consultative services regarding performance metrics to hospital departments, PI Teams and various Medical Staff Committees
Develops graphs, charts and tables using appropriate data presentation and analysis
Presents findings to project teams and supports the development of presentations to senior management
Assists with the implementation of new information software, including installation and structuring of databases, establishing data entry, auditing and reporting procedures for these databases
Oversees the performance of routine data quality audits on the various databases
Provides administration for internal and external data registries, demonstrating comprehension of registry guidelines, definitions and standards
Provides expertise and training in registry use
Actively participates in PI initiatives by accessing data and working cooperatively with the PI Coordinator and other personnel in evaluating quality issues and implementing new processes and procedures
Participates in Hospital/Network Committees as assigned
Establishes and maintains productive relationships with internal and external customers
Maintains current knowledge of technology and health care environment by attending appropriate continuing education seminars, users groups and reading related periodicals

Senior Clinical Document Management Specialist Resume Examples & Samples

Sufficient knowledge of regulatory requirements and guidelines (ICH/GCP to support clinical records management
Solid communication skills and strong customer focus with ability to interact in a global, cross functional organization
Ability to communicate effectively with external vendors, including issue escalation, training and responding to enquiries and concerns
Experience with use of Electronic Data Management Systems

Senior Clinical Trial Materials Management Specialist Resume Examples & Samples

Participate in the development, review and approval process of departmental procedures and work instructions
Assist in drafting and submitting Request for Quotes
Participate in CMO management including negotiation of contracts
Assist with tracking budget accruals against completed jobs
Participate in drafting and publishing Pharmacy Manuals
Traveling to CMO’s for operations and audits as needed
Minimum of a Bachelor’s Degree with 5 years of experience working in a cGMP Manufacturing, Quality Assurance and/or Quality Control environment in the pharmaceutical industry (an equivalent combination of education and experience may be considered)
Two or more years of related experience with a working knowledge of supply chain operations, clinical trials management and or drug development preferred
Working knowledge of GMP, GCP and associated regulations
Planning, project management, negotiation and facilitation skills
Sound judgment, analytical and decision making skills
Ability to manage and prioritize multiple projects and studies

Senior Clinical Supplies Management Specialist Resume Examples & Samples

Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supplies Contract and Supply Order for Phase I through IV clinical protocols with minimal supervision
Participates on and/or leads Clinical Supplies Delivery Teams
Reviews Clinical Research Development Programs and coordinates development of yearly clinical supplies forecasts
Protocol interpretation and breakdown
Represent the Clinical Supply Packaging Group at team/R&D meetings to update and forecast the status of projects
Manage approval process of labels required to complete packaging according to Medical, Regulatory and FDA requirements
Monitor the shipping and returns of clinical trial materials to and from investigational sites
Create reports and documents to facilitate and record every aspect of all operations performed or projected
Independent and effective coordination of supply requirements for local and international studies, comprising forecasting, scheduling of manufacture/packaging/foreign language labeling, storage/shipping/hazardous materials/export, and knowledge of regulations
Interacts effectively with international groups on supply issues
Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs
Demonstrates a comprehensive understanding and is knowledgeable in the development of IVRS system requirements for drug supply management
Demonstrates a comprehensive understanding and is knowledgeable in the development of Rest Of World Depot sourcing for drug supply management
Demonstrates a comprehensive understanding of the drug development process and requirements of IND/NDA submissions
Demonstrates knowledge and possesses experience in multiple clinical supplies projects
Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures
Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals
Effectively organizes and conducts meetings, and demonstrates facilitation and listening skills
Gives effective presentations to departmental and interdepartmental groups

Senior Clinical System Analyst Resume Examples & Samples

Experience interacting with physicians on a regular basis
EPIC build and implementation experience preferred
Bachelor Degree and/or professional certification in a clinical field
This is an exempt position and may require overtime, on call rotation and travel
Excellent written/verbal communications
Strong customer service, analytical and problem solving skills
Working knowledge of healthcare environment and processes

Senior Clinical Trial Operations Manager Resume Examples & Samples

Provide oversight of a study to ensure progress according to study timelines. Lead the clinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study. Liaise with the feasibility manager to review and assess country feasibility. Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors’ specifications and oversee vendor activities and deliverables (i.e., Central Lab, IVRS,
Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility; Definition of the Case Report Form content and testing of the end product. Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing) and completion guidelines, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the CTT. Review other CTT and vendor-developed or co-developed documents (e.g. specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality). Ensure appropriate testing/UAT are performed as required (e.g. eCRF screens, database structure, data loading, etc). Ensure that clinical and data management standards are followed for the study data management, monitoring Meeting Planner)
Organize study specific meetings (CTT excluded). Coordinate and support field-monitoring activities through regular meetings: teleconferences and/or visits to CSU’s, training of monitoring teams, investigator meetings. CRO management if applicable. Prepare and lead data review meeting, organize and contribute to medical review meetings
Participate in the development/follow-up of the study budget and selection and management of vendors. Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study in collaboration with the Clinical Purchasing department
Preparation and oversight of study audits/inspections both internal and external. Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to CTT and/or DPE and Team Leader. Develop and implement immediate action plan at global CSU/sites level if needed
Provide oversight and preparation for FDA pre-approval inspections (PAI). Upon request, prepare and assist in PAI preparation plan with the PAI project team. Utilize designated tools developed to oversee quality (e.g. Polaris BO reports, etc) for an Inspection-readiness approach and to prepare for CSU CTTs & DRS meetings to optimize monitoring efficiency & quality
Mentors/trains new comers. Participate, as a delegate to TL, to the training of new CTOMs on therapeutic area and general responsibilities within their function
Dedicated Project Expert (DPE) role: The Dedicated Project Expert (DPE) is a role performed by a senior Clinical Trial Manager (CTM), senior Study Data Manager (SDM) or senior Clinical Trial Operations Manager (CTOM) in addition to his/her direct study responsibilities; direct study responsibilities may be adjusted depending on the coordination activities workload of the designated clinical program. The DPE is accountable for operational oversight of the clinical program conducted within Trial Operations. He/she coordinates with CTM(s), SDM(s) and CTOM(s) working on the designated program to ensure operational consistency, to identify possible synergies, and to ensure that the team works closely together to meet the program goals on time and with good quality. The DPE assists the CSO CSP Project Leader (PL) in developing/ following the execution of the program operational statement. The DPE is the primary point of contact for PL within TO and will represent CTMs/SDMs/CTOMs working on program as the designated CSO CSP Project Team Member. He/she is the primary responsible person for escalation of program issues/information within Trial Operations and will ensure that PL and TL are being provided with regular reporting on the program progress. The DPE provides input to help TL ensure alignment according to risk adjustment and study milestones
2+ years of prior management and/or supervisory experience

Senior Clinical Innovation Manager Resume Examples & Samples

Acts as the subject matter expert for the on-label use of respective product line(s) and supporting documentation
Collaborates with product management to conduct quantitative and qualitative market research with customers in order to develop the product requirements definition for new and existing products and services
Defines customer requirements for new and existing products and services
Develops and manages limited product releases (LPRs)
Participates in market and competitive analyses and in the development and implementation of marketing plans to meet the strategic goals of the product line(s)
Serves as central marketing point of contact for technical questions from the sales organization and health care providers; confers with internal product experts and the medical office when necessary; provides timely responses and guidance for on-label product use. Refers off-label requests to the Medical Information & Communications office
Consults with cross-functional teams to determine course of action in order to translate recommendations into product and program improvements. Acts as the clinical liaison for the product line between the RTG Sales, Clinical Staff, Medical Office, Marketing, Customer & Technical Services, Quality, Regulatory, Legal, Compliance, Global R&D, Global Manufacturing and Operations (GMO), and customers. This includes product and service training and updates for these cross-functional teams
Work with product management and marketing communications teams to develop marketing communications, clinical support, & promotional and merchandising tactics consistent with the overall product line strategy
Acts as liaison between RTG Sales, Clinical, Quality, and Product Management on the identification of quality issues to develop product line improvement strategies, including enhancement of training tools and techniques, as well as recommendations for technical modifications
Communicates product or service needs to product management to collaborate on a resolution strategy. Such needs may include, but are not limited to: education and product line support needs, quality issues, new or existing product use, and/or clinical practices
Participates in Corrective Action Preventive Action (CAPA) activities, Field Action Decision Form (FADF) completion, Patient Safety Committee (PSC) meetings. Responsible for presenting marketing team’s response to all field actions and quality issues
Reviews patient facing documentation regarding recalls, FADFs and other materials to ensure it is at a correct reading level and accurately explains the information
Performs unstructured testing to simulate customer use upon request by R&D
Performs verification of product line user guides/instructions for use on production-quality equipment annually and upon request
Implements and complies with International Standard ISO Regulations and Good Manufacturing Practice for Medical Devices, 21 CFR part 820
Participates in risk analyses, offering clinical input where appropriate
Develops and implements comprehensive multi-disciplinary staff training programs on product line, as needed
Applies and adheres to company SOPs for Design Control and Change Control for equipment, disposable products and literature items pertaining to Instructions for Use (IFU) and promotional materials
Conducts train-the-trainer sessions for new and existing products, services, and support materials on a regular basis with the Clinical Support Specialists and/or Medical Support Specialists to ensure on-label use and up-to-date information is delivered
Conducts product demonstrations with customers at meetings and symposia, as requested
Participates in competitive analysis, monitoring, and communication to key stakeholders, as needed
Collaborates with the Sr. Clinical Education Manager to define the clinical education and support needs for the market and provide product expertise to assist in the development of these tools
Participates in the Promotional Materials Review Committee, as needed
Attends trade shows and scientific congresses related to the renal market
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
Assist with various projects as assigned by a direct supervisor
Minimum of 5-8 years of clinical experience in hemodialysis and/or peritoneal dialysis is required; with a Master’s Degree only 3 years of experience required
2 to 3 years of experience in Healthcare Marketing/Product Management is preferred
Experience in Project Management is preferred
Proficiency with Microsoft Excel, PowerPoint, and Word
Proficiency with iOS and Android software operation is preferred
Analytical and problem solving ability, excellent interpersonal and communications skills, creativity and business acumen, multi-tasking and project management skills
Strong clinical presentation skills and the ability to present to audiences of various sizes and educational backgrounds
Demonstrated track record of success and career progression

Senior Clinical Systems Technician Resume Examples & Samples

Provide Tier I support for the Physicians Direct Connect line
Provide direct support for Physicians on all hardware, network and applications FMC utilizes
Assist Physicians' user account issues as needed. Issues can range from password resets and locked accounts
Provide Tier II support for various application systems as well as performing coordination and tracking of other day to day activities with the goal of ensuring consistency across all Business Units
Responding to calls and Remedy Tickets
Identifying and researching the problem
Determining the appropriate action for resolution and implementing
Research and evaluate technical information and scripts and online departmental procedures for problem resolution
Monitor and review the tracking system for problems and issues. Track tickets from start to finish
Work with clinical staff and management to evaluate and revise current clinical processes to take advantage of Clinical software functionality
Work effectively as a project team member with technical and functional personnel to complete key project milestones and deliverables
Assist the Business Unit with company-wide implementations
Prepare supporting documentation, as appropriate, in accordance with FMCNA standards
Responsible for collaborating and participating in assigned projects and IT initiatives
Provide technical assistance and mentoring to Clinical Systems Technicians
Educate users on FMCNA and IT policies and procedures as necessary
Participate and/or lead additional projects both as an individual and as a part of a team as directed to enhance clinical support functions for clinical systems
Mentor and train new Clinical Systems Technicians
Effectively communicate properly structured and well thought-out emails/verbal communications to field resources, internal customers and peer IT departments
Provides 24/7 on-call support

Senior Clinical Coverage Review Medical Director Resume Examples & Samples

10+ years clinical practice experience required
5-10 years managed care experience required
Significant record of performance, by meeting and exceeding operational goals in health care quality and cost management
Proven success in change management and innovation
Excellent presentation skills for both clinical and non clinical audiences
Strong sense of personal and professional responsibility

Senior Clinical Team Leader Resume Examples & Samples

Communication - Keeps project leadership apprised of team issues. Maintains timely and effective communication among team members and site staff. Attends Kick-Off, Quick Start, and Investigator meetings
Monitoring and Oversight - Reviews the study scope of work, budget, and protocol content. Provides training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study. Leads weekly project calls with CRAs. Responsible for site assignments for CRAs. Ensures study specific training requirements are completed and documented. Provides assistance and/or co-monitoring with regional team for high enrolling or problematic sites. Collaborates with internal project team members to assure timely site initiation process. Facilitates the site selection process utilizing Quick Start methods and appropriate feasibility assessments, if applicable. Assists the PM with tracking site initiation status, including Institution Review Board (IRB) approvals and scheduling of site initiation visits to coincide with shipment of clinical supplies. Reviews site visit reports according to Company or Sponsor requirements. Reviews Clinical Trial Management System to provide oversight and to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to contracted project scope. Requests clarifications and corrections to the visit reports, follow-up letters and other site correspondence. May serve as subject matter expert on implementing study specific factors into the trip report. Reviews system reports to track CRF collection/entry and quality. Assists with clinical listing reviews
Business Development - Prepares and presents materials for bid defense meetings. May support proposal development including creation of monitoring strategy
Administrative - Provides status reports to the PM and the Sponsor on-site initiation, enrollment, visit(s) scheduled, and trip report completion

100

Senior Clinical Information Analyst Resume Examples & Samples

Bachelor of Science degree required
Minimum of 10 years of working experience with at least 5 directly within the healthcare field
Strong analytical, organizational, and problem solving skills
Strong experience with SQL query writing required
Hands-on experience with analyzing data
Experience with BI tools/ Dashboard Development
Clear understanding of common healthcare standards and nomenclature such as ICD9/10, CPT, SNOMED, LOINC, etc
Clinical applications experience is a plus but not a requirement

101

Senior Clinical Trial Lead-immunoscience Resume Examples & Samples

Qualified individuals must possess an MD (or equivalent) or MD/PhD degree. Therapeutic background flexible, but rheumatology, gastroenterology, CV, inflammation/immunology and/or autoimmune disease background are preferred
Experience with heath authorities and regulatory submissions
Comfortable working in a fast-paced environment where speed is paramount
Willing to work outside of a traditional functional environment, in a team unified around serving the assets

102

Senior Clinical Application Analyst Resume Examples & Samples

Experience: Four (4) years working knowledge of hospital departmental operations
Experience in supporting complex problems
Experience assisting other analysts
Demonstrates pattern of growth in ability to lead others
Demonstrated record of good communication skills
Industry training and increasingly responsible experience with knowledge and skills in a large, complex corporate Information System
Strong knowledge application support, development tools and methodologies
Three (3) years of increasingly responsible experience in a large, corporate systems development and implementation activities in a wide variety of Healthcare Management Information Systems (MIS) technical experience in system analysis, design, building, testing and implementation preferred
Technical Administration – Responsible for providing technical knowledge in the support of software applications and various system environments. Perform the analysis, design, building, testing, and implementing of computer programs and systems. Demonstrate and apply information systems theory, processes and methodologies. Reason: To effectively provide the technical skills required to successfully support system programs and applications that meet the technical requirements defined by MH. Apply appropriate theories and procedures that meet the business objectives of the company
Planning & Coordinating – Develop, prioritize and execute projects according to established schedules and timeframes. Maintain an effective level of coordination on all assigned projects. Document and report on all plans, priorities and schedules. Inform Manager or Director on status of all projects and assignments in the form of weekly activity reports. Reason: To ensure an effective method of planning and coordinating project management, as well as ensure that projects are completed according to set schedules, and reported to management on a regular basis
Systems Development – Translate user systems needs into alternative technical solutions. Perform project reviews and process walkthroughs incorporating technical and business solutions that will enhance user productivity and department service levels. Reason: To provide the technical skills required to successfully design, develop, deploy and maintain the technologies needed to satisfy user and applications strategies at a minimum cost and with maximum effectiveness
Technical Standards – Act as an advocate for setting and enforcing technical development, application support and information management standards within and outside of the information systems department. Reason: To ensure that standards are established and followed consistently for the benefit of the company
Application Support – Demonstrate in-depth knowledge and techniques in supporting Clinical Application Analysts and Lead Clinical Application Analysts in development projects and complex problem solving efforts. Participate in after-hours technical support by rotating call schedule on a regular basis. Reason: To provide resolution methods and alternatives to problems that can jeopardize the processes and workflow of MH’s systems. To provide technical solutions to critical issues
Training – Prepare and conduct training sessions for staff. Reason: To ensure staff is trained and knowledgeable in the use of computer programs and systems
Customer Service – Provide effective Customer Service by being courteous, polite and friendly toward others at all times. Acknowledge customers immediately in order to determine need and help the customer resolve issue or request. Reason: Consistently display behavior that enhances the image of organization as evidenced by professional and courteous behavior toward all customers
Other – Perform other duties and special projects as assigned by others. Adheres to all MH policies, procedures, and standards, within budgetary specifications, including time management, supply management, productivity, and accuracy of practice. Promotes individual professional growth and development by meeting requirements for mandatory/continuing education, skills competency; Supports department-based goals which contribute to the success of the organization; Serves as preceptor, mentor, and resource to less experienced staff

103

Senior Clinical Study Assistant Resume Examples & Samples

Complete patient interviews over the phone for those patients who are no longer following up in the office and/or schedule appointments if patients are willing/able to come in
OnCore registration and maintenance for all studies and PowerTrials registration and maintenance for all studies
Sample collection, processing, storage, and pickup from pathology lab, shipping samples as needed, create enrollment folders for all studies as needed, poster printing and pickup when necessary, kit building as needed
Late day clinic coverage (shift 9a-5:30p) In person patient interviews when coordinators unavailable
Filing completed research forms including Consent/HIPAA documents, case report forms, and administrative forms
Extract data from EMR for Minimal Risk Studies as directed

104

Senior Clinical Engineering Technician Resume Examples & Samples

Completes scheduled maintenance in accordance with PM Inspection and Protocol management plan
Assists other technical positions in Clinical Engineering and other departments in the organization as required
Attends service schools, in house training or self-directed study as required on higher end equipment and systems
Performs and/or assists in installation of higher end systems
Graduate from an electronic technical school required

105

Senior Clinical Engineering Technician D Resume Examples & Samples

Initiates and completes documentation after repair or PM is completed
Licensure/ Certification/Registration:Current driver's license may be required
Minimum of 3 years’ experience performing direct repair and maintenance of general biomedical devices and systems, plus an additional 2 years repair and maintenance on higher end devices required

106

Senior Clinical Trials Specialist Resume Examples & Samples

Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, and relevant study plans and charters)
Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks
Participates in the development, review and implementation of departmental SOPs and processes
Travel 10-15% or more of the time

107

Senior Clinical Systems Specialist Resume Examples & Samples

Utilize system technical expertise to produce ad-hoc queries and metric reports providing information essential to business requirements
Utilize Business Intelligence Applications (e.g. Spotfire, OBIEE) and Excel/PowerPoint to communicate information to stakeholders in a clear, concise and impactful manner
Understand financial and performance metrics requirements within region and/or project
Perform bug fixes and program enhancements
Serve as team member for application enhancements or special projects, upon request
Ensure the consistent use of designated clinical systems and/or procedures for assigned projects; conduct QC checks on reporting and source data, collaborating with others as needed to ensure better quality data
Provide support to a designated region (multiple offices) or local office for designated analytics
Participate in the development of system specifications and documentation, as well as user testing of new enhancements / functionality and/or review of associated procedures, training and documentation
Review and execute test cases; sign off and document test cases
Identify and record quality problems; suggest, initiate, recommend or provide solutions as appropriate
Receive the specific training for the position in order to update their knowledge
Adheres to all relevant associated SOPs/Work Instruction and other guidelines
Develop and update training material with new procedures, system changes, analytics etc.; and provide training on designated clinical systems and analytics to local and global colleagues

108

Senior Clinical Data Prgrming Lead Resume Examples & Samples

Serves as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of simple to moderately complex design, with competent clinical data delivery experience and knowledge
Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets
Reviews specification documents created by study teams, such as data transformation specifications and programming specifications
Co-ordinates and manages study database updates and out of scope impacts as specified per change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
Serves on project teams to coordinate and lead development activities for multiple clinical data programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources
Trouble-shoots and solves study data delivery issues and/or external data integration issues and/or change request issues using the appropriate applications
Ensures high quality deliverables by providing senior review of study level/program-level/multi-study core deliveries for accuracy
Attends sponsor audits and assists with in-progress audits, including presenting the Clinical Data Delivery process and procedures and pretending the validation documentation produced by the Clinical Data Services Group
Ability to run existing programs to produce internal and Sponsor deliverables
Provide ongoing support, mentorship and training as appropriate, to members of the CDMS or CDS team involved
Bachelor’s degree in information systems, science or related discipline
Minimum 2 years experience building study databases or 4 years experience in clinical data programming
SAS Programming experience required
Proficiency in CDISC
Trained in Data Standardizing
Proficiency in Business computer skills
Documentation skills
Thorough knowledge of ICH Guidelines and GCP including regional regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
In depth knowledge of clinical trial process and data management, clinical operations, and systems applications to support operations
Demonstrated organizational skills to handle multiple competing priorities simultaneously across an assortment of projects and initiatives

109

Senior Clinical Laboratory Systems Analyst Resume Examples & Samples

Results reporting via interfaces to EMR’s on campus (EPIC, Meditech), and via our fax server for external clients
Instrument interfaces (all automated analyzers, printers, scanners, peripherals)
Reference lab interfaces with both on campus and off campus reference labs
SMART (specimen tracking and routing)
Billing file/interface troubleshooting Reporting interfaces to Department of Health/Tumor registries
Maintain lab related master files residing in Epic EMR (e.g. EAPs, LRRs, etc…)
Work the interface error queues from all laboratory interfaces that feed the Epic EMR

110

Senior Clinical Neurophysiology Specialist Resume Examples & Samples

EEG and evoked potentials experience preferred
Database design, bio statistical analysis, volumetric multimodal image reconstruction, surface-based image reconstruction experience preferred
Intermediate proficiency in Microsoft Office: Excel, PowerPoint, etc
Ability to follow written, verbal and diagrammatic instructions in order to solve complex problems and file basic reports

111

Senior Clinical Specialist Atrial Fibrillation Resume Examples & Samples

An Associate’s Degree in nursing, biology, chemistry or exercise physiology filed PLUS a minimum 5 years of work experience in in AFS Industry OR
Bachelor’s degree PLUS a minimum of3years of work experience in AFS Industry
Ability to travel more than 75% of the time
Experience in the cardiac catheter ablation field, EP lab, in a hospital/clinic or EP medical sales providing technical / clinical support
PHYSICAL JOB REQUIREMENTS
Clinical Specialists are required to be within their assigned territory each day to be available as unscheduled needs arise
Clinical Specialists will on occasion be required to travel outside of their assigned territory and possibility overnight
Ability to freely move throughout the facility, use a phone, keyboard and mouse, visually able to interact with personal computers
Must be able to stand/sit/walk for 8 hours a day

112

Senior Clinical Evidence Specialist Resume Examples & Samples

Bachelor’s Degree (biomedical or scientific)
5+ years of experience in clinical research and/or medical device surveillance and/or clinical evaluations
Direct experience with medical and/or scientific writing within a medical device industry or related industry
Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRHF therapies and technologies
Ability to work independently (content originator) and collaboratively (content review among stakeholders)
Ability to translate engineering and marketing data into a device performance context
Demonstrated ability to apply analytical skills to effectively summarize, communicate and present clinical trial outcomes
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; clear and concise writing style
Demonstrated ability to identify and adapt to shifting priorities and competing demands for multiple projects and deadlines
Demonstrated ability to identify and overcome obstacles

113

Senior Clinical Pharmacokineticist Resume Examples & Samples

Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise
Publish research in peer-reviewed journals and present work at scientific conferences
Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program
Seize opportunities to pursue project relevant leads that are in line with the group’s strategy
Maintain a high level of productivity in the lab
Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable
May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals
Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
Possess thorough theoretical and practical understanding of own scientific discipline
Effective writer and communicator of research or other regulatory materials

114

Senior Clinical Transformation Consultant Resume Examples & Samples

Build and effectively maintain relationship with the practice leadership and key clinical influencers actively involved in practice transformation
Develop strategies; based on performance analysis, for improvement that includes specific outcomes and metrics to monitor progress to a goal and make recommendations for improvement
Monitor and review the progress of the practice in milestone achievement and insure the practice is accountable for successful completion
Use data to analyze key cost, utilization and quality data and interpret results to assess the performance of the practice
Use data to analyze trends and work with stakeholders to agree on and implement proactive strategies to address issues, and measure impact using a PDSA rapid cycle improvement approach; including external practice data
Assist practices in creating work flows to optimize care delivery, introduce best practices improvements, and evaluate outcomes using rapid cycle improvements PDSA methods to reach mutual goals
Educate & Deploy technology tools to support Practice Transformation
Consult and partners with internal UHC matrix partners and the practice to identify organizational and structural challenges hindering achievement of desired program outcomes
Bachelor's degree
5+ combined experience with improving clinical quality, health care analytics, or driving clinical transformation initiatives with population health programs, Patient Center Medical Homes or in Accountable Care Organizations
2+ years of experience interpreting and utilizing clinical data analytics, outcomes measurement in healthcare and use of that data to drive change
Strong Relationship building skills with internal and practice teams to drive goal alignment

115

Senior Clinical Admin Coordinator Resume Examples & Samples

Authorizes selected services per explicit criteria and guidelines
Collects data for clinical review and submits data to licensed clinical services staff for decision - making
Performs outbound patient calls per clinical pathway
Facilitates patient’s appointments as directed by the case manager
Manages a case load of 100 - 150 low acuity patients that are identified for population management by the case manager
Provides feedback to Clinical Services Supervisor regarding process improvement
Experience working with ICD-9 and CPT codes
Experience working with Medicare and / or Medicaid Services

116

Senior Clinical Dept Admin Resume Examples & Samples

HUMAN RESOURCE MANAGEMENT: Effectively performs personnel tasks including counseling and disciplining staff as appropriate. Completes performance evaluations in a fair and timely manner. Monitors performance efficiently to explain appraisal rating and to prevent serious problems. Ensures appropriate staffing. Ensures compliance with institution-wide and departmental policies. Assures appropriate performance and specific competencies in-service education programs, and outside educational programs. Effectively mentors staff to maximize skills, knowledge and abilities. Supports teamwork, problem-solving, and offers technical and procedural consultation
GOVERNANCE & ORGANIZATIONAL DYNAMICS: Develops strategic marketing plans and effectively implements such plans. Collaborates with other departments to further develop services. Evaluates existing services and identifies new opportunities. Uses political and social networks positively for the benefit of the department and organization
3, FINANCIAL MANAGEMENT: Provides timely and complete budget variance reports. Completes justification for capital equipment, including pro forma and payback analysis. Makes continuous efforts to ensure cost-effective, efficient operations. Ensures the charge master is continuously updated based on an RVU methodology
BUSINESS AND CLINICAL OPERATIONS: Ensures departmental compliance with all of regulatory agencies and all regulatory compliance to include State Board of Medical Examiners for MD and PA, State Board of Nursing, OSHA, CLIA, Department of Labor, CMS and other such agencies. Ensures proper maintenance of the environment and equipment via the proper department managers. Ensures sufficient staffing. Addresses internal/external complaints about employee or department performance and resolves efficiently and timely. Quantifies department efficiency and effectiveness through benchmarking and continuous quality improvement. Develops and implements strategic plan as well as ongoing goal and objectives to support the plan. Develops and maintains a strong relationship with physicians and identifies areas for business opportunity and support. Aggressively identifies new markets for program growth
QUALITY MANAGEMENT: Quantify department efficiency and effectiveness through benchmarking and continuous quality improvement methods. Ensure compliance with TTUHSC quality initiatives to improve department health care delivery and patient safety. Develop and oversee departmental patient satisfaction and customer service programs. Identify, develop, and maintain benchmarks for establishing department performance standards. Create internal processes and systems to participate in pay-for-performance programs to enhance health care quality within the department
EDUCATION/PROFESSIONAL DEVELOPMENT: Serves as a mentor to, and promotes, professional development of staff. Ensures personal professional growth and development
DEPARTMENT SPECIFIC RESPONSIBILITIES: Displays fairness and consistency in recommendations and decision affecting staff. Exercise discretion and maintains confidentiality in all matters relating to the clinic, its employees, and patients. Accountable to Department Chair for all operations, education and research initiatives. Management of Departmental Contracts. Collaborates with Department Chair on all strategic initiatives. Support Chair decisions on operational, educational and research initiatives. Attend all faculty meetings. Seek input from faculty on operational, educational and research initiatives
INSTITUTION & SOM DUTIES: Support Service Plus Initiatives. Actively promote the SOM Key Performance Indicators (KPIs) of Patient Satisfaction, Quality, Financial Performance, Business Development, IT/EMR/IDX, and Managed Care

117

Senior Clinical Applications Analyst Resume Examples & Samples

User Support
Supporting existing clinical applications including installing upgrades, providing enhancements and problem management
Resolving support issues according to Information Systems policies, providing documentation to Clinical Applications Analysts for future reference
Providing consultation on process analysis and design, recommending alternative solutions, both automated and manual, to meet those needs
Acting as liaison between Information Technology vendors and internal departments
Serving as liaison to major user groups, including Nursing, Physician and Allied Health, on information systems issues
Serving on or leading appropriate RIC committees
Providing after-hours on call service as required
Facilitating and supporting system installation through the implementation cycle
Determining goals and objectives of each project and identifying all stakeholders, taking into consideration the provision of quality patient care, user needs and potential for cost savings through reduction of work steps
Identifying customer functional requirements and translating functional requirements into system design, ensuring that systems deliver the desired capabilities to meet the needs of the users
Assisting with product selection based on identified functional requirements
Participating in the design and deployment of medical device and foreign system interfaces between 3rd-party systems and Cerner Millennium
Developing a project plan with timelines and milestones based on priorities and resource requirements
Defining roles and responsibilities related to the project
Developing and implementing a communication plan to include project progress
Developing conversion/migration requirements and life cycle plans including designing, configuring, testing, debugging, implementing and documenting phases
Configuring Cerner modules
Developing detailed Unit Test plans, executing tests to verify configuration satisfies design requirements, and updating configuration based on results
Developing and documenting Integration Test and User Acceptance Test plans based on functional specifications
Managing vendor relationships
Documenting and managing issues and problems including establishing a course of action to ensure that goals and objectives are achieved
Coordinating handoffs to operations, support and technical staff in Information Systems
Developing documentation for training, maintenance and support, including problem resolution and escalation decision trees
Complying with Policies and Procedures regarding IT Change Management
Working with clinical representatives after the conclusion of IS projects to measure results of initiatives
Maintaining current knowledge of trends in information systems
Continually meeting certification requirements described in “Knowledge, Skills & Abilities Required” by completing continuing education per Cerner Corporation’s specifications
Assisting with development of plans, strategies and tactics for employee education to support new and existing system applications
Developing end-user training materials for applications software as needed
Collaborating with the Applications Analysts to provide user training, conducting training sessions as necessary
Serve as mentor/coach to Clinical Applications Analysts
Evaluating and monitoring training for effectiveness
Bachelor degree in information systems (e.g. Computer Science) or clinical care (e.g. RN, PT, OT, etc.). Work experiences can replace traditional educational requirements
Current or prior certification in one or more core clinical modules (e.g. Cerner Application Specialist, Cerner Integration Architect, etc.). Certification(s) must be consistent with current Cerner modules in use at RIC
Project Management Professional (PMP) or healthcare Informatics credentials a plus
Minimum of 5 years experience in an Information Systems Applications Analysts role
Minimum of 5 years experience with clinical system tools (e.g. Cerner Millennium)
Knowledge of rehabilitation healthcare processes in one or more area
Proven ability to manage software initiatives of varying sizes and complexity
Experience working within Windows operating systems and Microsoft Office tools
Personal computer skills necessary to prepare project plans, presentations, flow charts, test plans, etc
Firm knowledge of workflow in one or more area and ability to work independently with users to define how technology can drive business processes
Analytical skills necessary to resolve issues and/or increase operational efficiency of the patient care process
Ability to pay close attention to details when designing, implementing, documenting and maintaining system functions
Interpersonal skills necessary to actively listen and communicate effectively with IS peers and user community to deliver and support systems based on user needs
Strong team-building skills to promote cooperation, collaboration and partnership both inside and outside the organization
Critical thinking and reasoning skills to identify strengths and weaknesses of alternate solutions, conclusions and approaches to problems
Organizational skills necessary to coordinate the completion of tasks independently as well as with others to meet established deadlines
Work well under pressure
Knowledge of Cerner Command Language (CCL) for troubleshooting
Ability and willingness to learn new tools and Healthcare Information Systems (HIS) to be identified as part of RIC’s future core applications toolset. Example technologies include new Cerner modules

118

Senior Clinical Risk Management Specialist Resume Examples & Samples

Identification, assessment and recommendations for corrective action of liability loss potential
Development and implementation of liability loss prevention program and
Maintenance and coordination of liability claims and control
Bachelor of Arts or Bachelor of Science degree
Four or more years of Hospital Management, Risk Management or Insurance experience
Four or more years of inpatient hospital experience preferred
A Georgia Licensed Registered Nurse is strongly preferred
Hospital critical care experience strongly preferred
Must be self-motivated and self-directed, strong problem solving ability, self-reliant and ability to work under pressure
Strong organizational and analytical skills required including experience with database systems
Strong knowledge and familiarity with healthcare/clinical processes and standards of care as applied to professional and general liability
Above average communication skill, both oral and written with a variety of customers, both internal and external
Good leadership skills and professionalism, as well as confidentiality of all functions is required
Claims Management experience preferred

119

Senior Clinical Affairs Specialist Resume Examples & Samples

As a project leader to lead the whole study activities, including but not limited to site selection, Ethic's committee review, study agreement signing, investigator meeting, enrollment, trial master file management, site monitoring, source data verification and site close-out
As a project leader to manage and track the study timeline, study budget and products of company sponsored studies
Ensuring the clinical studies are in compliance with local regulations, ICH GCP and Thermo SOPs
Establishing and maintaining the good relationship with investigators and sites
BS or higher in healthcare field, major in clinical medicine or pharmacy is prioritized
A minimum of 5 years experiences in medical devices industry, at least 3 years in full cycle clinical trial process express
5 years work experiences in multinational company
Familiar with CFDA regulations on MD/IVD registration
Good communication skill cross function and cultures

120

Senior Clinical Study Assistant Resume Examples & Samples

Order and maintain supplies required for study procedures. Manage financial aspects of supply ordering including recordkeeping
Set up research study room including ensuring availability of all necessary materials and supplies
Assist with non-nursing tasks during the performance of bedside studies
Perform quality control measures on measurement devices in the study room. Maintain study-related equipment
Blood sample handling and storage. Label and process all lab specimens and arrange for shipping or local storage
Maintain computer and paper records for study data and laboratory sample record-keeping
Perform routine bench top assays including radiation surveillance testing

121

Senior Clinical Program Leader Resume Examples & Samples

Provides the key strategic interface between a pRED DTA and pRED Clinical Development
Accountable for the translation of the DTA strategy into effective implementation and delivery for all pre-LIP molecules in accordance with the quality, timelines, resource, and cost commitments of the DTA
Line manage Clinical Program leaders (CPLs) assigned to the DTA and will work closely with other sub-function representatives within pRED Clinical Development supporting the DTA
A key member of the DTA Portfolio Committee which drives the strategic direction for the portfolio and a core member of the Development Review Committee which provides critical technical reviews of project team clinical development plans
Plays a critical role in contributing to the clinical development project plans to enable flexible and innovative development of operational strategies
Contributes to the continuous development and innovation of the function and beyond including in the definition of functional strategies, deployment of budget and resources and support of the development of processes and systems tailored to the early development setting
Proven knowledge of external service providers and needs for drug development within a DTA and the ability to understand and critically assess global clinical development strategies and plans, innovative protocol designs, resources needs, global budgets and timelines for multiple programs across the therapeutic area
Experience implementing clinical development plans using a range of operational models and clinical program/study designs
Proven ability to create new and novel concepts to resolve complex challenges and to support innovation even outside of your immediate role remit
Provide specialized operational support to internal and external stakeholders and maintain relevant knowledge of business, regulatory, and therapeutic advances that may impact life cycle planning or ongoing operational strategies
An excellent understanding of clinical drug development across the value chain within and beyond the specific DTA. Requires a strong knowledge of the competitive landscape and key business drivers for increasing the probability of technical success
Significant project management and direct line management experience
An effective team player with exceptional interpersonal and communication skills (globally, internal and externally) with experience of working and leading large matrix teams
Willingness to travel internationally and work across cultures is necessary along with the ability to take on broader leadership responsibilities as necessary
Significant project management and direct line management experience as well as the ability to manage through influence in a matrix organization

122

Senior Clinical Trials Specialist Resume Examples & Samples

Leads and drives the project team in the planning, execution and management of all operational aspects of clinical trials
Ensures the project team maintains a continuous state of audit readiness
Recruits, manages and develops Principals, Associates and Specialists. Mentors and coaches all level of Project Management
Bachelor’s degree and 5+ years of related work experience or an equivalent combination of education and work experience
Ability to respond flexibly and positively under conditions of uncertainty or change
Ability to apply comprehensive knowledge and experience to resolve complex issues in creative ways
Peripheral Interventions or Oncology clinical trial experience desired
Contract Research Organization (CRO) experience
Wide-range of clinical trial operations experience strongly preferred (ex: Site Management, Monitoring, Data Management, and/or Safety)

123

Senior Clinical Program Consultant, Namm Resume Examples & Samples

Cultivate existing relationships and develop new relationships with vendors with the goal of ensuring sufficient resources, and ability to provide services
Develop and implement strategies that will maximize the synergies among program areas in a matrix approach
Lead and manage key day-to-day operational aspects of the vendor clinical programs with emphasis on enhancing effectiveness through performance improvement
Instill a sense of accountability among team members by modeling tight oversight of individual and organization performance standards
Coordinate with Managers and Directors to implement a system to evaluate the skill, experience, and professional development needs of all staff to facilitate success of new and existing programs
Oversee training and orientation of all staff members to all supportive programs
Oversee the launch and execution of new programs as needed and facilitate the development of score cards/program dashboards
Establish consistent, objective program performance standards of accountability
Collaborate with the HC Economics team to determine annual ROI requirements and manage to these objectives
Liaison with key stakeholders which include internal stakeholders, physicians, EC Committees, members and their families
Coordinate the development of and oversight of all communication materials related to the programs
Understand and live the spirit of integration as opposed to assimilation for new partner groups and IPA entities
8 or more years of Healthcare experience
3 or more years of management experience
3 years of Program development/implementation experience
Strong computer skills: PowerPoint, Excel
Bachelor's or Master’s degree preferred
Managed Care experience

124

Senior Clinical Technologist Resume Examples & Samples

5% - Attend bone marrow aspirations to obtain specimens on patients with leukemia or lymphoma
25% - Establish short-term cultures, and prepare metaphase cells from cultures, and prepare microscope slides and stain metaphase cells to induce Giemsa banding patterns
45% - Perform accurate and timely cytogenetic, FISH, and microarray analyses
5% - Prepare preliminary and final reports describing the results of cytogenetic analysis. Record accurate data into computer database
10% - Participate in laboratory tasks, such as (1) performing and oversee the ordering of supplies and maintaining laboratory inventory, (2) Serving as the Laboratory Safety Officer to assure compliance with established safety and quality control procedures, and maintain ongoing compliance with all CAP/CLIA laboratory standards; or (3) Assisting the Laboratory Directors in the preparation of the laboratory for on-site inspections by helping to update laboratory documentation related to quality control procedures and all relevant safety documentation
5% - Assist Laboratory Directors in planning, developing and validating new analytical tests
5% - Instruct new personnel including technologists, residents, medical students, and fellows, and others individuals in a broad range of cytogenetic, FISH, and microarray techniques

125

Senior Clinical Supplies Management Specialist Resume Examples & Samples

Effective coordination of supply requirements for local and international studies, including continuous forecasting, communicating manufacturing needs, and scheduling of packaging/labeling activities
Monitor IP for duration of study and ensuring appropriate stock levels are available for study requirements. Continue to monitor budget, depots and monitor IRT after study start. Ensure IP reconciliation is completed
Works on routine assignments, and applies knowledge and experience in learning new procedures
Report and Protocol Writing: Create reports and documents to facilitate and record every aspect of the operations performed or projected
Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supply Master Plan for Phase I through IV clinical protocols Oversight
Effectively organizes and conducts meetings
Represent GCSM at CMC/Clinical meetings to update and forecast the status of projects
Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans

126

Senior Clinical Data Programming Lead Resume Examples & Samples

Leads study specific database design projects within the InForm CDMS system, leading clinical database programming activities on multiple studies of complex design
Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS)
Builds clinical study database CRF screens per CRF Specifications provided by project team
Creates/Programs edit checks, special actions/functions, custom programs and derivations as per a DVS
Plans and schedules edit check test script writing, edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File
Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
Configures study specific data interfaces such as IVRS, labs, and CTMS
Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources
Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS failures, CTMS issues), and/or change request issues using the appropriate applications
Creates advanced CDMS custom programs as per DVS, as required
May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations, testing and reports
Participates in special projects or tasks related to the assigned CDMS as directed by the CDMS Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress
Maintain confidentiality of management information as appropriate
To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Data Management department initiatives
To act as a bridge between the Clinical Data Programmers and Validation Group within CDMS. Addressing technical clarifications and providing guidance as needed
Maintaining all necessary study documentation for the CRF build and edit check
Keeps up-to-date with all software developments and release notes of assigned primary CDMS system. Research and self-training is required to ensure that CDMS knowledge, particularly in relation to system functionality, is current
Ensures all queries to the CDMS group are responded to in a timely manner, particularly when trouble-shooting an issue or answering a system functionality question. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved
Proven experience in building study databases using InForm CDMS
Demonstrated ability to learn new technologies, applications and techniques

127

Senior Clinical Transformation Consultant Resume Examples & Samples

Bachelor's degree or equivalent relevant experience
Willingness to travel up to 25% for face to face meetings
Active, unrestricted RN license in the State of residence

128

Senior Clinical Operational Excellence Manager Resume Examples & Samples

Manage the contribution from TM to the design or revision of controlled processes (e.g. Standard Operating Procedures (SOPs). Provide guidance for departmental subject matter experts and coordinate input from other Novartis Institutes for BioMedical Research clinical functions
Operational management for CS&I or TM compliance or process improvement activities from inception through to communication, implementation and training
Partner with Clinical Quality Assurance to support clinical teams in preparation, conduct and follow up of audits and health authority inspections. Coordinate preparation and completion of Corrective Action Plans
Manage mandatory training curricula for employees in collaboration with QA. Manage onboarding standards and maintain an overview of additional training to support associates and managers in customizing training plans. Lead or support development of training for competency building
Manage departmental document templates and provide TM contribution to new or revised global templates (e.g. clinical trial protocol template)
Monitor and promote compliance with training and other regulatory compliance (e.g. code of conduct, SOPs, GCP), provide updates to functional managers and ensure remedial training is undertaken. Proactively identify areas of concern and propose process or training improvements based on findings. Manage documentation and follow up SOP and process deviations together with Clinical QA
Support clinical teams in addressing quality or compliance problems
Actively support TM in building and sharing knowledge on quality requirements and processes by providing guidance, sharing Lessons Learned and maintaining supportive tools and platforms
Support identification, overview and prioritization of process improvement activities to enhance operational excellence and regulatory compliance in clinical TM
Represent CS&I and clinical TM groups in relevant cross-functional working groups related to quality implementation, process management and training
Deputize for Operational Excellence Expert or next level line manager on request
Maintain and continuously build knowledge of process improvement, training and change management methodologies and best practices

129

Senior Clinical Engineer Resume Examples & Samples

Manages vendor relations including procurement, warranty and service agreements. Serves as vendor liaison: monitors performance and obtains relevant service documentation. Facilitates client & vendor communication. Ensures vendor provides information, documentation, software, tools, and training necessary to operate/service technology with inclusion of terms and conditions for vendor compliance
Bachelor's degree in Electrical or Biomedical Engineering required. Master's degree in Biomedical or Clinical Engineering preferred
5-8 years related work experience required
Demonstrated experience in project management, planning of complex projects, communication and interaction with large IS departments required
Advanced experience in the clinical environment with understanding of the operational structure and typical processes in the hospital setting required
Knowledge of Human Physiology and Anatomy, understanding of engineering principles in the application of clinical devices/technologies and complex medical devices, and extensive knowledge of computer networks and integration of medical equipment required
CCE and/or PMP certification preferred
Understanding of human factors engineering in the design and usability of medical devices and interfaces preferred
Customer Service:Ability to provide a high level of customer service and staff training to meet customer service standards and expectations for the assigned unit(s). Resolves service issues in the assigned unit(s) in a timely and respectful manner

130

Senior Clinical Systems Manager Resume Examples & Samples

Responsible for developing strategic direction for Clinical Science (CS) operating systems utilization and functionality by partnering with CS leadership to ensure implementation plans are realized Serves as the SME providing overall system and project team support Oversees the Clinical Planning and Managing System issue resolution process with CS
Serves as primary CS representative to provide strategic direction in a cross functional setting for long-term system implementation
Leads the planning and management of internal and external resources to execute the ESQA validation oversight of system implementation plans and audit and compliance programs. Interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project-related initiatives
Manages the CS Super User Mailbox and works directly with project teams to resolve issues in a timely fashion
Provides oversight to audit plans and ensures compliance to related systems that are required to be used within Clinical Science
Serves as Clinical Science representative on assigned cross-functional project teams associated with portfolio and program management; responsible for identifying process improvement initiatives, ensuring budget and timelines requirements are met and provides guidance, direction, and support regarding systems compliance, resolution of compliance issues, provides update reports to management, and ensures completion of CS project related action items
Oversees and establishes training modules/lessons around systems, which could include on boarding of new CS personnel and identifying needs for any ongoing training programs
Responsible for planning, scheduling, and ensuring performance of periodic reviews of Clinical Systems Manual and Algorithm in order to ensure appropriate training and to ensure communication of changes is conducted on a timely basis. Monitors and ensures the completion of the training. Provides periodic update reports to management
Primary liaison between CS and other functional areas regarding systems
Evaluates trend/issues, proposes systems/process improvements and recommends Best Practices
Responsible for leading the Super-Users, fosters global collaboration, discusses current issues and brainstorms on best practices
Partners closely and collaboratively with finance and assist teams during budget forecasting cycles
Provides functional oversight for multiple Clinical Systems Managers and/ or contractors to ensure consistency of implementation across systems, regions and teams
Bachelor's degree and 7 years of related experience in clinical operations with systems management experience or Master's Degree with at least 5 years of experience
Experience managing phase II and/or III clinical studies within the past 5 years
Proficient computer skills across multiple applications and with budget/timeline software systems
Training in Regulatory and System Compliance
Applied GXP experience in pharmaceutical or biotechnology industry with clinical drug development experience
Knowledge of the Pharma Development business process and conduct of Clinical Trials
Ability to interact and network effectively with internal customers and external vendors
Basic presentation and communication skills, negotiation and follow-up skills
Dedication to customer service, and experience delivering on customer needs
Basic understanding of available business and clinical databases within Astellas
Forward thinking and creative solution development
Works well individually and demonstrates good people/team skills
LI-BR

131

Senior Clinical & Outcomes Program Manager Resume Examples & Samples

7+ years of experience in the health care industry
Clinical experience required
RN, MS, MPH, MBA or PhD preferred
7+ years experience in a clinical environment with experience in telehealth patient management
3+ years experience with publications and/or data analysis
Ability to travel nationally 30% or more with flexibility
Ability to effectively manage multiple priorities and projects and execute on all projects
Excellent verbal, writing and presentation skills
Analytical and data-driven decision making skills
Persuasive communication skills, ability to communicate complex information, issues, and potential solutions across the enterprise
Ability to rapidly understand business requirements and communicate business expectations to cross-functional technology development teams
Clinical research study and/or quality improvement study design and execution
Proficient in Microsoft Applications such as Word, Excel and Power Point

132

Senior Clinical Specialist, Crhf, Dayton Resume Examples & Samples

A High School Diploma plus 9 years of clinical specialist experience with a medical device pacing company, OR
An Associate's Degree plus 7 years of clinical specialist experience with a medical device pacing company (or 6 years with 2 years of prior healthcare or engineering experience), OR
A Bachelor’s Degree plus 5 years of clinical specialist experience with a medical device pacing company (or 4 years with 2 years of prior healthcare or engineering experience)

133

Senior Clinical Systems Anlyst Resume Examples & Samples

Completing analysis, design, develop, testing and implementation of new interfaces
Providing maintenance, support, and coding enhancements for existing interfaces
Interface Engine administration including application of updates and patches

134

R&D Senior Clinical Engineer Resume Examples & Samples

Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment
Conducts feasibility studies to verify capability and functionality
Develops new concepts from initial design to market release
Directs support personnel and coordinates project activities
Write and submit intellectual property (patents)
Maintains detailed documentation throughout all phases of research and development
Investigates and evaluates existing technologies
Reviews or coordinates vendor activities to support development
Establishes and cultivates an extensive network of support to facilitate completion of assignments
Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel
May lead a project team
Participates in determining goals and objectives for projects
Influences middle management on technical or business solutions
May interact with vendors
Plans and organizes non-routine tasks w/approval
Initiates or maintains work schedule
Establishes priorities of work assignments
Exercises judgment in selecting innovative, practical methods to achieve problem resolution
Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources
Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred
Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact

135

Senior Clinical Engineer Resume Examples & Samples

Routinely evaluates the equipment maintenance procedures and schedules to ensure optimum level of equipment maintenance with efficient resource utilization. Develops procedures for routine QA inspection of all new medical instrumentation. Evaluates current procedures to ensure efficient resource utilization and maximization of equipment up time. Develops procedures, test setups, and report forms for each type of newly acquired instrument. Develops in-service programs for user and maintainer training for each type of device. Re-evaluates programs and procedures on an ongoing basis. Reviews equipment incident records with emphasis on identifying any possible need for changes in the equipment maintenance program. Assigns PM schedules and priority
Responsible for all aspects of staff recruitment, hiring, training, scheduling, and supervision. In the absence of the Director will assume responsibility for overall supervision of all department activities. Assigns workload according to staff skills, priority, and schedules. Monitors the daily work performance of staff. Conducts in-service training for all clinical engineering staff on the proper procedures for maintaining and repairing each device. Defines the expected outcome and time of completion of assignment clearly to the employee. Solicits feedback from employees to make sure the assignment is understood. Interviews prospective employees and makes recommendations regarding training. Recognizes the need to counsel subordinates and performs counseling in a timely fashion. Offers guidance for improving performance to the employee. Brings to the employee’s attention areas of performance needing improvement as soon as they are recognized with a plan and a time frame for correction. Responsible for the performance review process. Responsible for the planning and development of staff training programs. Trains Biomedical Technicians effectively and maintains records of staff performance and training. Encourages staff to pursue continuing education and seek professional growth. Distributes educational material/literature to staff as it becomes available
Participates in cost control activities by seeking the most effective method of delivering services, and maintains an awareness of the cost impact of decisions and actions. Participates in cost control activities by seeking the most effective method of delivering services and maintains an awareness of the cost impact of decisions and actions. Assists in preparing the annual budget in a timely fashion. Monitors and analyzes funds, purchasing activities and brings discrepancies, major pattern changes, and key issues to the Director’s attention. Utilizing audit results, analyzes program changes regarding impact on spending patterns and department budget
Assists the Director in preparing and analyzing the operating budget. Respects and maintains the confidentiality of all patient, physician and hospital related information. Cooperates and communicates effectively and harmoniously with own supervisor, management, peers, general staff, physicians, other medical Center personnel, patients, their families, and the general public in a courteous and professional manner. Communications are well thought out, effective and informative
Participates in the planning and development of departmental policies, new programs, protocols and test maintenance procedures. Communicates the need for new or revised policies and procedures to the Director in a timely manner. Submits monthly reports on equipment maintenance programs on time. Develops short and long-range plans for the accomplishment of departmental goal, and addresses all contingencies in a plan. Measures the effectiveness of a plan through predetermined methods. Anticipates deviations from plans and recommends solutions/alternatives. Communicates status reports of projects and plans in a timely manner. Presents new and innovative ideas, gives ideas appropriate follow-up, and if necessary makes adjustments. Understands the department’s mission, goals, and objectives, and takes appropriate actions to meet these
In the absence of the Director, will assume responsibility for overall supervision of all departmental activities. Makes good judgments, which are based on gathering and analyzing factual and objective data; is able to interpret policies and procedures in order to make a sound independent decision. Demonstrates alertness and adaptability to changing Medical Center conditions; responds appropriately. Makes decisions in a timely manner
Participates in the development and operation of the Medical Center equipment management program. Assists in maintenance of the equipment inventory program, updating information as necessary. Performs pre-purchase evaluations of medical equipment and submits reports to the Director. Performs incoming inspections of devices; ensuring that units are matched with the purchase order, meet all applicable standards that appropriate test procedures are developed and assign priority rating and PM schedule. Ensures that all purchased equipment is properly identified and recorded as NYU Hospitals Center property prior to testing. Assists in the review of service contracts with emphasis on cost and quality control. Makes recommendations regarding alternatives to the Director. Performs routine Quality Audit reviews of equipment to assess the performance level of the maintenance systems, and to assess the need for PM schedule adjustments. Develops and implements in-service education program for both instrument users and maintainers, making specific recommendations on annual retraining needs. Assists in the performance of incident investigations where medical equipment is involved, recording all details of the status of the equipment
Bachelor’s degree in Biomedical Engineering or Electrical Engineering
Minimum of four years professional experience
CBET eligible
Masters of Science in Biomedical Engineering/Electrical Engineering
CBET Certification
Experience working in a union environment with some supervisory/leadership experience strongly preferred

136

Senior Clinical Computing Analyst Resume Examples & Samples

Bachelor's degree in Computer Science or Technology-related field or equivalent work experience
Four years of experience microcomputer and LAN support services, including problem analysis/resolution and installation
Two years of experience with Intel based platforms and LAN support services, including problem analysis/resolution and installation in a complex environment
Experience with Windows XP/Vista/Server 2003
Some MAC 10 experience helpful but not required
Some Linux experience helpful but not required

137

Senior Clinical Resume Examples & Samples

Registered Nurse with a minimum of 7 years of clinical and operational experience in an acute care setting. Bachelor’s Degree required
Prior hospital or industry management experience in managing direct reports preferred
Prior industry experience preferred
Knowledge of Baxter and competitive Infusion and Access products, and their appropriate use in the medication use processes
Excellent matrix and influence management skills
Articulate and comfortable with public speaking and teaching others
Ability to effectively interact with representatives from all levels of an organization
Strong analytical skills combined with proven business acumen
Self-starting, independent worker
High energy with innovative mindset
Team oriented and collaborative personality
Strong computer skills in Word, Excel and PowerPoint

138

Senior Clinical QS Manager Resume Examples & Samples

Certification as a Clinical Research Professional is desired
Laboratory experience required for toxicology review, process validation, and laboratory methods
Strong understanding of good manufacturing, clinical, and laboratory practices
Background in Quality Systems, with experience in clinical quality assurance or clinical quality systems group serving in a quality role desired
Excellent communication and writing skills; professional with high personal integrity and ability to develop good interpersonal relationships with healthcare professionals
Expertise in writing and revising Standard Operating Procedures
Proven ability to manage projects/teams of significant scope/complexity while meeting milestones
LI-BC1

139

Senior Clinical Traning Specialist Resume Examples & Samples

Provide comprehensive education and training for all clinical staff, existing and newly hired. Determine training needs, establish course objectives, develop, test and conduct training programs for clinical staff. These should be based on job functionalities and regulatory requirements, as well as uphold Highmark’s mission and corporate values. This is to include new hire orientation, training on/coordinating training on systems, clinical criteria, regulatory standards, operational policies, system navigation, primary health coaching, business processes, utilization management business processes and guiding through corporate new hire requirements. Clinical educational programs may include evidence-based medicine protocols, motivational interviewing, health coaching, and more
Provide comprehensive orientation for all newly hired health coaches and care managers. Working closely with the management team this individual is responsible for corporate and departmental mandatory training and ensures new hire training goals and objectives are met. As well as ensuring classroom material is kept up to date and availability to all staff
Expertise in Motivational Interviewing techniques, Health Coaching and/or Case Management principles
Expertise in nationally recognized utilization management criteria
Experience in Telephonic Coaching and/or Utilization Review Experience
Advanced knowledge of clinical platform functionality
Advance knowledge in Micro Soft applications
Effective oral and written presentation/communication skills required
Evidence of effective interpersonal skills, systems knowledge, analytic skills with ability to create action plans, and ability to work independently to achieve targeted results
Self-motivated and independent performer with the ability to work independently and prioritize assignments. Ability to work effectively and drive programs to completion within a transforming organization
Ability to embrace change management; work effectively in a fast paced environment while managing multiple complex initiatives
Support an environment of continuous learning
Familiar with regulatory agency requirements, including but not limited to CMS, URAC, NCQA, DOL, and DOH

140

Senior Clinical Quality Program Manager Resume Examples & Samples

The candidate will be responsible for preparing and presenting detailed reports on Pay for Performance, Sanctions, State, HEDIS and NCQA measures and requirements
Analyze all Performance and Quality Improvement (QIPs and PIPs) programs and projects
Understand statistical data and produce appropriate supporting reports
YTD and YOY comparison of performance
Ability to drive continual quality improvement (CQI) projects
Oversight and management of member and provider programs affecting DSNP, MMP and LTSS populations
Undergraduate degree or higher
Minimum 2 year Medicaid / Medicare regulatory experience
Minimum of two years of experience with designing, implementing and deploying continuous quality improvement initiatives
Proficiency with MS Office products to include Word, Excel, PP, Note and Access
Experience working in large data sets and ability to customize to the audience
Demonstrated successful Project Management experience
Ability to present analytic results to a wide range of audiences, both internal and external
Must be able to obtain a CPHQ within 6 months of employment, as required by the State of Ohio
Experience working as a statistical analyst
HEDIS and / or STARS experience strongly preferred

141

Senior Clinical System Analyst Resume Examples & Samples

Oversees intermediate size Epic projects or components of a larger Epic project
Utilizes clinical knowledge and expertise to evaluate Epic workflow challenges and patient safety initiatives. Communicates to non-clinical IT staff as needed to ensure clinical challenges are being addressed
Responsible for the Epic design, testing and implementation for the outpatient departments and clinics
Effectively analyzes production or operational problems, identifies and resolves immediate production problems. Responsive and accurate in recommended resolution
Participate in various work groups to recommend IT solutions that contribute to the workflow/issue resolution
Utilizes clinical knowledge and expertise to work with physician groups in guiding their design of system functionality and clinical content

142

Senior Clinical Engineer Resume Examples & Samples

Identify clinical needs for Rhythmia software development
Create collaborative partnerships for Clinical data analysis
Generate innovative prototype algorithms with analysis supporting the feasibility and clinical utility of the novel solution
Provide technical representation in Europe for Electrophysiology mapping technology and new software concepts
Support the EU business needs through collaboration with Marketing, Medical Affairs, and Clinicals
M.S. or PhD in Medical Engineering with expertise in cardiac electrophysiology
Experience with bio-sigal analysis, algorithm development, and computation modeling for cardiac systems
Working knowledge of clinical research in human subjects
Demonstrated ability to communicate and work in a clinical laboratory environment with key opinion leading physician-customers

143

Senior Clinical Trial Coordinator Resume Examples & Samples

Assists with document collection and review, site monitoring activities, data management tracking and query resolution and the management and administration of Study Team Meetings, including scheduling meetings, agenda circulation, and minute preparation/circulation
Obtain and track key study information as required, including site details, IRB submission and approvals, patient enrollment and screening data, informed consent (ICF) review and approvals, and other study specific details. Ensures reliable reports (including enrollment graphs) of patient/study status and screening metrics are provided to Leadership weekly
Responsible for maintenance of Trial Master File (TMF) documents, document quality control (QC) review, and transmittals/filing of documents in the TMF
Point of contact for internal and external key stakeholders including internal and external team members, vendors and corporate partners
Assists with shipping study related materials, including blinding material, patient labels, supplemental CRFs, and any other necessary supplies. As requested, provide study materials support to site personnel

144

Senior Clinical Affairs Specialist Resume Examples & Samples

Participate in multi-disciplinary internal/external teams to help define and implement successful clinical studies in support of division and corporate initiatives
Responsible for proactive management and conduct of investigational sites according to sponsor protocols and regulations including, but not limited, to study start-up activities, site selection, initiation, monitoring and close out
Support the development of study protocols, case report forms, informed consent templates, investigators brochures, clinical study reports, presentations and other study related documents
Create and maintain clinical project documents to provide routine status reports to Director, Clinical Affairs; Franchise teams, and VP Regulatory & Clinical Affairs in multiple forums including CTMS, and effectively track progress, communicate key issues, timelines and invoice payment status through study completion
Assist with IRB, FDA Clinical Trials website registration and other regulatory submissions upon request
Complete e-document Trial Master Files (TMF) per Corporate and regulatory standards via assigned software system
Interact and build positive relationships with investigational sites, vendors and other functional areas as primary project contact for clinical operations/on-site needs
Supervise investigational product accountability, manage supply shipments and inventory, subject screening/enrollment consenting procedures, case report form monitoring/retrieval, and query distribution to/retrieval from investigational sites, compliance with any core lab requirements, submission of data for analysis and invoice payment schedules based on project plan deliverables
Ability to perform relevant clinical literature searches for the purposes of protocol development
Support the development of medical device labeling including promotional material based on results of clinical research, including providing appropriate reference and support based on valid scientific evidence
Demonstrate understanding of Bard’s business functions, systems, and objectives. Possess working knowledge of all product portfolios and end-user application. Provide input on potential future projects for feasibility and research
Demonstrate independent thought and autonomy to creatively and effectively solve problems as they arise. Assess risks during on-site study management and implement effective resolution strategies. Involve and report risks immediately to Director
Document and report non-compliance and/or any clinical events in a timely manner, involve Director immediately wherever appropriate
Ensure that all clinical staff assigned to specific research projects are appropriately trained on protocol and study device, complete tasks in accordance with study protocol and project agreements, Bard procedures and applicable regulations. Oversee on-site activities and review work produced by the clinical team; (visit reports, correspondence, tracking reports, etc.); and
Assist in the development and implementation of standardized processes and procedures for conducting clinical research. Recommend and implement enhancements to clinical systems based on experience and/or metric data as appropriate
License in nursing with three (3) or more year’s clinical experience with vascular access devices
Certification in clinical research through ACRP, SOCRA or other related organizations
Prior experience in successfully managing project timelines, budgets, and project resources
Experience with domestic and OUS clinical trials
At least two (2) years of experience leading professional teams (internal and external) in a clinical research environment
Knowledge of scientific/clinical research and statistical methods
Knowledge of testing and clinical application of vascular access medical devices
Ability to work independently as well as collaboratively with internal staff and external partners such as consultants, scientists, clinical investigators, medical professionals, service vendors and CROs to lead and participate in highly functioning work groups in fast paced environment,
Strong working knowledge of Good Clinical Practice, FDA regulations, IRB submissions and current industry practices related to the conduct of clinical trials
Understand and interpret technical, scientific, and clinical information as it relates to product clearance and registration activities
Proven communication skills (oral and written) and public speaking skills
Strong computer skills, proficiency with Excel and database management, Microsoft Suite – Word, PowerPoint and other related trial management software applications

145

Senior Clinical Data Engineer Resume Examples & Samples

Bachelor's degree in computer science or related field or 5 years work experience
Extensive knowledge and demonstrated experience with a range of programming, markup, and query languages, including HTML, JavaScript, CSS, Python, Perl, SQL, etc
Extensive knowledge and demonstrated experience with web application development tools and frameworks, including Pyramid, Flask, Django, CGI.pm, mod_perl, Catalyst, JQuery, Dojo, YUI, etc
Advanced knowledge and demonstrated experience with relational and non-relational databases, including PostgreSQL, MySQL, MongoDB, etc
Extensive knowledge and demonstrated experience with database interfaces such as Psycopg, DBI/DBD, MySQLdb, JDBC, etc
Knowledge of and experience working with object oriented programming techniques
Extensive knowledge and demonstrated experience designing RESTful APIs
Demonstrated knowledge and experience working with large, complex biological and/or clinical data sets
Knowledge of FDA regulations, GCP, CFR Part 11, and ICH guidelines
Knowledge of Data Structure Standards (CDASH, SDTM)

146

Senior Clinical Program Leader Resume Examples & Samples

The Senior Clinical Program Leader (SCPL) NORD is accountable for the operational strategy, planning and execution of the clinical development portfolio up to LIP for the designated Discovery and Translational Area (DTA)
This person provides the primary interface between the NORD DTA and pRED’s the Clinical Program Execution (CPEX) function in Clinical Operations, oversight for program and study management, line management of key operational roles
As a member of the NORD DTA Portfolio Committee (DTA-PC) and the Development Review Committee (DRC), the SCPL, NORD is empowered to make key operational strategic decisions and provide technical review on behalf of clinical operations
As member of these committees, the SCPL, NORD provides direction and therapeutic area operational expertise and ensures effective implementation
The SCPL, NORD is accountable for delivery of programs with respect to quality, timelines, budget and ensures resources from the sub-functions of CPEX are available to the DTA. The SCPL, NORD defines the clinical operations sourcing strategy for their designated DTA and is accountable for the placement of programs
This person will have a good working relationship with internal and external stakeholders and have oversight of the management of Key Accounts with investigators and academic centers
This person will contribute toward the design of pRED CDPs and clinical protocols to enable flexible and innovative development of operational strategies with appropriate scenario planning, which include forecasting of timelines, resources and budget, as well as program level feasibility assessment
The SPL NORD will have responsibility as line manager of CPLs, SL Team Leaders and Documentation Specialist for the designated therapeutic area

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