Associate Director, Clinical Operations Resume Samples

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C Mraz

Consuelo

Mraz

4865 Osinski Summit

Boston

+1 (555) 500 9084

4865 Osinski Summit

Boston

Phone

p +1 (555) 500 9084

Experience Experience

Philadelphia, PA

Associate Director Clinical Operations

Philadelphia, PA

Harris-Hartmann

Philadelphia, PA

Associate Director Clinical Operations

Develops marketing strategies aimed at retaining and increasing membership, developing new markets and achieving strategic multi-payer opportunities
Develop plans for employee engagement including provider recruitment/retention, staff development, training, mentoring and performance management
Evaluate proformas and analysis for new business opportunities including the addition of new services or facilities
Develop and monitors key indicators for all aspects of clinic operations
Develops and participates in company-wide policy and procedures to monitor and ensure company and regulatory compliance and consistency
Develop and implement the strategic plan for Primary Care departments aimed at supporting financial, clinical, cultural and customer service goals in conjunction with physician leadership
Work with division management teams and Physician leaders to develop and manage operational budgets for business units

Los Angeles, CA

Associate Director, Clinical Operations

Los Angeles, CA

Tremblay, Denesik and Hartmann

Los Angeles, CA

Associate Director, Clinical Operations

Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
Administers clinical operational plan, and incorporates the study and scientific plan
Manages operations teams responsible for multiple early stage clinical programs (Phase 1 and 2 studies)
Interacts within a matrixed environment that includes subject matter experts in clinical, project management, regulatory, commercial, manufacturing, discovery research
Conduct pre-study, site-initiation, monitoring, and closeout visits
Train CRAs/CRO in conduct of such visits
Manage clinical supplies, work with and manage CROs and recruit investigators

present

Phoenix, AZ

Associate Director, Clinical Operations Dcri

Phoenix, AZ

Rutherford, Durgan and Boehm

present

Phoenix, AZ

Associate Director, Clinical Operations Dcri

present

Serve as a The Associate Director, Clinical Operations within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
Serves as the liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility and may serve as a member of the clinical trial/study/program core team
May serve as a contact for clinical trial sites
Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
Plan, track and manage assigned projects budgets to ensure adherence to business plans
May interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel

Education Education

Bachelor’s Degree in Life Sciences

University of Massachusetts Amherst

Bachelor’s Degree in Life Sciences

Skills Skills

Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
Excellent interpersonal and organizational skills and ability to deal with competing priorities
Detail oriented with strong problem solving and decision making skills
Strong communication, educational/pedagogic, diplomatic and empathic skills
Leverages resources, expertise and knowledge across projects
Registers study protocols on ClinicalTrials.gov, as applicable
Excellent oral and written English language skills
Ability to lead across several dimensions simultaneously
Mange direct reports, if applicable
Strong understanding of clinical trial planning, (site) management and metrics

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Associate Director, Clinical Operations Resume Examples & Samples

Requires deep knowledge of Good Clinical Practices
Expertise and knowledge in the application of regulations and standards applied in clinical areas/regions is required
Advanced project management skills with ability to handle multiple projects
Demonstrated competencies in the following areas are required
Presentation skills and influencing of others
MS or PhD is preferred
A BS with at least 10 years of experience, MS with at least 8 years of experience, or a PhD with at least 6 year of relevant experience is required
A minimum of 2 years of people management experience is required
Significant previous experience in clinical project leadership across multiple studies/programs required is required
Experience with budget planning, tracking and control is required

Associate Director, Clinical Operations Resume Examples & Samples

4 year degree
5+ years of experience managing inclusive of front line and management staff
2+ years of experience reviewing performance metrics and performance reports, interpreting and analyzing data, and creating action plans accordingly
2+ years previous call center management
Experience interfacing with multiple levels in a complex health care operation, health insurance, or other business environment
Proven, demonstrated communication and presentation skills
Proficient with Excel, Word, PowerPoint, Outlook
Highly adept organizational and prioritization skills
Excellent team and relationship building skills
Master’s degree in Health Administration or Business Administration
Clinical Licensure in Nursing or Behavioral Health
Experience with state and federal health care compliance

Associate Director, Clinical Operations Resume Examples & Samples

Accountable for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) program, expanded access programs, and compassionate use programs
Demonstrated ability to manage international programs within designated program budgets and timelines is required
Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
Contributes to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents
Represents the company at professional events and may present company clinical initiatives and findings at such events
Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems
Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines
Experience with delivering presentations before executive staff is required
Directs development of SOPs within department and participates in development of collaborative SOP development
Excellent verbal, written, interpersonal skills and ability to lead multifunctional teams manage staff and mentor junior staff is required
Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required
Must meet all requirements for the Senior Clinical Project Manager position and have demonstrated proficiency in all relevant areas
At least 10+ years of experience and a BS or BA in a relevant scientific discipline
At least 10+ years of relevant experience and a MS degree
At least 10+ years of experience and an RN (2 or 3 year certificate)

Associate Director, Clinical Operations Resume Examples & Samples

Administers clinical operational plan, and incorporates the study and scientific plan
Manages operations teams responsible for multiple early stage clinical programs (Phase 1 and 2 studies)
Interacts within a matrixed environment that includes subject matter experts in clinical, project management, regulatory, commercial, manufacturing, discovery research
Conduct pre-study, site-initiation, monitoring, and closeout visits
Train CRAs/CRO in conduct of such visits
Manage clinical supplies, work with and manage CROs and recruit investigators
Organize investigator meetings and set up internal systems as needed
Assist in writing study protocols, final study reports, SOPs, safety reports, and design and implement CRFs
May assist with development of study related documents and overall direction for the clinical sites to establish protocol development
Ensures compliance with Good Clinical Practices, Good Manufacturing Practices, and regulatory guidelines
Assists with development and management of clinical budget and the development of contingency plans for clinical trials
Acts as a cross functional liaison to ensure study plan aligns with business development strategies
May perform background research analysis and ongoing research analysis during the conduct of the clinical trials
Develops Case Report Forms, Informed Consent Forms, and IRB submission materials
Evaluates clinical data, data quality, and other study information to assist in providing interim and final reports on projects
Prepares research reports by confirming Case Report Form (CRF) and Severe Adverse Event (SAE) reporting, identifying protocol deviation, summarizing information, citing patient response, adhering to federal guidelines
Collects information by searching and interviewing investigators and patients, comparing information discovered to information specifications, and preparing correspondence
This position requires travel to investigator meetings and medical conferences, as well as occasional interactions with study sponsors and their staff
BS/BA degree in a scientific or medical discipline; advanced degree preferred
Directly applicable experience in clinical operations including operationalizing Oncology studies required
Experience operating effectively within a matrixed environment
Prefer experience in the life science industry/Pharma and start-ups
Must have advanced skills with the Microsoft Office suite
Proven ability to prioritize tasks, meet deadlines and be flexible with changing priorities
Ability to work independently, collaboratively, and demonstrate initiative
Must maintain strict confidentiality
Strong leadership skills and proven ability to lead internal employees of all levels as well as external collaborators and vendors
Must be able to read and interpret documents and write and present complex materials

Associate Director, Clinical Operations Resume Examples & Samples

Contributes to development of strategic plans for Clinical Operations and helps to translate strategic decisions into actionable operational plans
Contributes to development of departmental goals and objectives to achieve corporate goals
Oversees departmental resourcing and recruitment to ensure proper timing and allocation of resources to projects to achieve study timelines and deliverables
Partners with other functional areas within Study Management (Start-Up, TMF), with other functional departments across Vertex and with CROs/vendors to ensure clinical trials are executed on time, within budget and with quality
Defines and monitors key performance indicators and departmental metrics for Clinical Operations and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions)
Directly manages Clinical Operations staff (Clinical Project Managers, Clinical Trial Managers, Clinical Trial Associates) with responsibility for staff training, performance management, setting individual employee goals and career growth opportunities for staff. Also manages contract staff, who may be remote to Vertex’s offices
Plays a key role in oversight of CRO partners and other vendors, including issue remediation and governance
Participates in departmental and cross-functional process improvement initiatives, often as initiative or workstream
Bachelor of Science degree in a life sciences discipline, advanced degree preferred
At least 10 years of relevant work experience in the biopharmaceutical industry, with experience executing clinical trials globally across all phases of development
Excellent understanding of GCP, CFR and ICH guidelines Significant experience with line management of 10-15 employees
Proven track record of successfully overseeing staff to deliver clinical trials on time, on budget and with quality while ensuring inspection readiness
Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team and to effectively manage external vendors/CROs
Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment

Associate Director, Clinical Operations Resume Examples & Samples

Participates in departmental and cross-functional process improvement initiatives, often as initiative or workstream leader
Excellent understanding of GCP, CFR and ICH guidelines
Significant experience with line management of 10-15 employees

Associate Director, Clinical Operations Resume Examples & Samples

Evaluate and project resource needs on an on-going basis; Ensure the implementation of clinical studies through efficient allocation of LTMs, SMs and Administrative Associates
Participate in / lead business-related task forces to improve processes
Responsible for knowledge of GCO SOPs and fulfilling the responsibilities per those SOPs
Responsible for ensuring adequate, timely and compliant monitoring and management of clinical studies conducted in their Therapeutic Area(s)
Responsible for ensuring that team meets project deliverables according to timelines, within budget, and with quality
Ensure studies are in a constant state of inspection readiness
S(He) will communicate with staff on program changes, policy changes, and priority shifts on a regular basis
Be aware of issues affecting staff's workload and efficiency
Inform supervisor and fellow managers of potential problem situations and work closely on problem resolution
Participate in Management Staff meetings; Conduct staff meetings
A minimum of a Bachelor's Degree is required
In addition, a minimum of 8 years of experience in Clinical Research from the Pharmaceutical, CRO and/or Biotech industry is required
Candidate should have a good understanding of the therapeutic areas where J&J is involved is preferred
Experience with the direct management of employees or equivalent experience in a matrix environment is required
Experience managing and executing clinical trials is Required
Experience in Oncology is Required
Demonstrated experience coaching and mentoring clinical operations team members is preferred
Knowledge of FDA regulations as it pertains to GCPs is preferred
Proficiency with standard computer programs is required
Must have excellent oral and written communication skills, along with strong presentation skills, and the innate flexibility to work in a rapidly growing organization
This position requires up to 25 % annual travel, primarily for meetings and accompanied site visits

Associate Director, Clinical Operations Resume Examples & Samples

Demonstrate expert working knowledge of GHI study initiation, execution, analysis and closing procedures; study-related documentation; and study, program and business goals and achievements
Evaluate, recommend and present standard methodologies and process improvements to program and/or Clinical Operations leadership to improve efficiency and effectiveness of study initiation and execution
Participate in Standard Operating Procedure (SOP) development, training, and implementation
Monitor study progress from study initiation through publication of study results, including but not limited to maintenance of the study timeline, execution of actions by study team, and regulatory and protocol compliance
Guide junior CTM’s on Good Clinical Practices (GCP), monitoring activities, and compliance
Ensure the utilization of project management tools and standard methodology processes and procedures, to support efficient and effective study execution
Lead study and clinical team meetings; provide direction to CTAs to coordinate study and team meeting details
With study team members, identify and prioritize potential problems, challenges and solutions relative to program and business goals
Use judgement to identify and present study problems, challenges and recommended solutions requiring partner concern to clinical and program team leaders
Facilitate the development and timely completion of study-related documents, including but not limited to protocols; and data management and analysis plans
Ensure the accurate and timely delivery of study-related progress reports to program leadership and senior management
Lead effective collaborator communications for specimen tracking, study conduct and/or data review, including written communication, teleconferences and face-to-face meetings
Prepare budget and forecasts to Finance and Business Development leaders
Participate in assessment and recruiting new Clinical Operations team members
Mentor junior CTMs and CTAs; may directly lead lower level Clinical Operations staff including hiring, goal setting, coaching and development activities
Post-graduate course work in a life sciences, scientific or other relevant discipline
Ability and enthusiasm to lead, hire, mentor, develop, retain, and inspire the best talent
Prior experience leading employees

Associate Director, Clinical Operations Resume Examples & Samples

Responsible and accountable for one or more concurrent clinical studies
Develops and manages trial budget & MS Project timeline
Leverages resources, expertise and knowledge across projects
Manages the direction, planning and execution of the clinical trials including RFP process and vendor selection
Maintains oversight of the CRO and is responsible for the quality of CRO work through regular review and evaluation of work product throughout the duration of the trial
Identifies and reports potential issues effectively and in a timely manner and implements corrective action
Develops status reports and participates in the dissemination of clinical information to internal stakeholders
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
Reviews critical study documents created by CRO including informed consent forms, study conduct documents such as Study Operations Manual (s), training material, study tools etc
Participates in protocol development and review of CSR
Coordinate and lead cross functional teams as needed
Works with clinical supplies on study drug quantities and packaging requirements
Contribute in the review of data management related activities
Participates in reviewing and approving investigational sites based on complete site assessment by CRO
Participates in contracts and budgets negotiations with clinical sites and vendors and facilitates review with legal department
Participates in the coordination of investigator meetings and all other study management meetings
Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits
Mentors indirect reports, trains team members, including vendors, as needed
Review and contribute to the development of departmental SOPs
Minimum 3-5 years relevant industrial Clinical Project Management and 7-10 years of Clinical Development experience
Thorough understanding of clinical trial methodology, GCP/ICH and drug development process
Experience with CRO/vendor management
Good verbal and written communication skills, works effectively/congenially in a team setting
Excellent interpersonal and organizational skills and ability to deal with competing priorities
Detail oriented with strong problem solving and decision making skills
Ability to provide appropriate leadership to clinical sites
Independently motivated, capable of changing direction quickly if needed

Associate Director, Clinical Operations Resume Examples & Samples

The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally
The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated)
The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols
The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents Merck/MSD in Pharma industry issues and in seeking influence in external R&D environment
The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
The ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include
Strong understanding of clinical trial planning, (site) management and metrics
Strong communication, educational/pedagogic, diplomatic and empathic skills
Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
Strong organizational skills with demonstrated success required
Ability to lead across several dimensions simultaneously
Excellent oral and written English language skills
Problem solving and conflict resolution
Negotiation skills with both internal and external groups

Associate Director, Clinical Operations Resume Examples & Samples

Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee)
Uses operational and therapeutic expertise to optimize trial design and execution; works with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc
Prepares and/or reviews study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals)
Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments)
Works with relevant functional groups and study team to select sites and countries; develops relationships with investigators and site staff
Develops and manages study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs/SWPs; participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical
Minimum 8 years experience in the pharmaceutical industry in a position performing clinical operations functions
Must have previous start-up and overall mgmt. of large phase 2 or phase 3 trials
Must be responsible for managing a study budget in excess of $50M
Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
Strong clinical study management skills
Requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills

Associate Director Clinical Operations Resume Examples & Samples

Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process. Evaluate current methods and develops office/region based tools for onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs
Allocate resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training. May participate in country/region coordinated resourcing process
Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. This review may include review of written materials, soliciting internal and external customer feedback, and review of project assignment completion. Identifies quality risks and issues and create appropriate corrective action plans
Ensure that staff is meeting defined workload, quality and budget metrics through regular review and reporting of findings as outlined by clinical operations management
Act as a coach and mentor for staff members as they develop in their roles. Collaborate with project leadership including the PM and other functional leadership to manage project related challenges and to achieve exemplary customer service. Act as an adjunct CRS or CPM as needed to support achievement of study objectives
Participates in corporate or departmental quality or process improvement initiatives
Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Excellent organizational and problem solving skills
Effective time management skills and ability to manage competing priorities

Associate Director, Clinical Operations Resume Examples & Samples

Lead manager of protocols; prepares protocol, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial
Provides study updates to internal team, including management team
Registers study protocols on ClinicalTrials.gov, as applicable
Prepare required regulatory documents, provides updates for annual reports, IB, and final study reports for assigned protocols
Assist in the identification and management third party vendors, including development of Request for Proposals (RFPs), scope of work (SOW) documents, and vendor specifications
Participates in investigator meetings and follow up
Coordinates and plans for the availability of non-clinical supplies necessary to meet study requirements
Travel to sites when necessary
Coordinate activities related to audit findings and/or identification of significant site noncompliance
Develop relationships with Key Opinion Leaders
Participate in Clinical Advisory Board (CAB) Meetings
Mange direct reports, if applicable
The candidate must have a BA/BS degree or equivalent; health science degree or biologic science degree is preferred. A minimum of 8-10 years experience in the pharmaceutical industry, with minimum 5-8 years direct experience in planning and managing clinical trials
The candidate should have significant experience with responsible roles in the conduct or management of Phase I – III clinical trials
The candidate must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines
Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage budgets

Associate Director Clinical Operations Resume Examples & Samples

10 years of pharmaceutical industry experience
8years of experience in clinical research
3 or more years of line management experience

Associate Director Clinical Operations Resume Examples & Samples

Develop strategies to implement organizational mission, vision and values that optimize patient outcomes and financial performance; facilitates excellent customer service and satisfaction while achieving organization-specific financial goals
Develops and participates in company-wide policy and procedures to monitor and ensure company and regulatory compliance and consistency
Develop and implement the strategic plan for Primary Care departments aimed at supporting financial, clinical, cultural and customer service goals in conjunction with physician leadership
Work with division management teams and Physician leaders to develop and manage operational budgets for business units
Develop and monitors key indicators for all aspects of clinic operations
Develop and monitors annual Capital budget and the CAR process
Evaluate proformas and analysis for new business opportunities including the addition of new services or facilities
Develop plans for employee engagement including provider recruitment/retention, staff development, training, mentoring and performance management
Develops marketing strategies aimed at retaining and increasing membership, developing new markets and achieving strategic multi-payer opportunities
Ensure compliance with federal and state regulations as well as company policies, processes and procedures
Accountable for interviewing, selection, orientation, development, evaluation, discipline and competency of the division staff
Actively participates as the organization’s representative on boards, community and health-related agencies
Advanced skills in budgeting, financial analysis and cost accounting
Strong leadership and organizational skills including: group and team building, coaching, communication of vision, change management, and people/product focus balance
Ability to create and maintain a caring culture
Bachelor's degree in public health or related field; and/or equivalent and relevant experience in lieu of degree
3+ years’ experience (5+ years’ experience in lieu of degree) in medical practice management, health plan operations or Medical Management in management positions with successive promotions
5+ yrs. thorough knowledge of capitation, physician recruitment, contracting managed healthcare systems, medical quality assurance, quality improvement and risk management
Knowledge of (or ability to learn and apply to job function) state and federal laws, regulations and compliance issues applicable to operating units
Well-developed knowledge of managed care principles and customer service best practices
Sound knowledge of financial and accounting concepts
Proficient in Microsoft Office, Excel and Powerpoint
Knowledge of ICD-9/CPT/HCPCS and medical terminology required
Ability to float among 4 Primary Care Clinics
Must possess strong analytical skills
Demonstrate ability to lead groups successfully coupled with strong interpersonal, excellent oral and communication skills
Valid NV Driver’s license
Master's degree in Health Care Management or related field
IDX knowledge, especially BUR preferred

Associate Director, Clinical Operations Resume Examples & Samples

Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors related to clinical trial conduct, including budget and contract negotiation and supervision of vendor activities
Develop study management plans that include enrollment milestones, risk mitigation, financial oversight, and communication and monitoring plans
Contribute to the development of study protocols to ensure operational feasibility and success in meeting study objectives
Collaborate with Medical Directors to identify study investigator and sites; facilitate sponsor-site relationships
Ensure execution of study progress according to timelines and goals
Plan and lead, in collaboration with Medical personnel, internal review meetings to communicate study progress, identify and provide solutions to clinical trial issues and risk, and to ensure timely decision making by the team
Prepare study progress reports for senior leadership
Liaise with Clinical Supply to provide drug supply forecasts
Work with Medical Directors and study team to develop data communication plan
Lead planning and execution of Investigator, Steering Committee, and vendor meetings
Develop best practices and SOPs, as necessary, to be applied to phase 4 study program
Attend medical conferences, as needed
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Bachelor’s or advanced degree in a scientific or healthcare discipline preferred
8+ years clinical development experience in the biotech/pharmaceutical industry
Experience in managing both interventional and observational studies preferred
Thorough understanding of FDA, EMEA, ICH and GCP guidelines, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal affairs
Extensive experience in managing clinical programs, CROs, budgets and timelines
Protocol, ICF, and CSR writing experience required
Strong working knowledge of MS Project or other project management software
Ability to function at a high level when leading a group or managing clinical research staff
Experience in both interventional and observational studies preferred
Experience in oncology preferred

Associate Director, Clinical Operations Resume Examples & Samples

Experience in the following areas is highly desirable: GVHD (Graft-Versus-Host-Disease), Cardiovascular, Interventional Radiology, Multipotent Stem Cells
Accountable for one or more concurrent clinical studies
Maintains oversight of the CRO and is responsible for the quality of CRO work product
Identifies and reports potential issues effectively and implements corrective actions
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses are developed and executed
Reviews critical study documents created by the CRO including informed consent forms, study conduct documents such as Study Operations Manual (s), training material, study tools etc
BS Degree in science or a health related field. PhD, RN(Nurse Practitioner) or P.A. are preferred
Minimum 7-10 years of Clinical Development or Clinical Project experience
Must be able to travel 5%-10%, domestically and internationally

Associate Director, Clinical Operations Dcri Resume Examples & Samples

Leadership, including proven ability to function effectively in a matrix organization
Managerial development # Information technology and systems analysis
Organization, planning, and prioritization
Facilitation
Analysis and problem-solving
Oral and written communications, including public speaking
Continuous quality improvement theory and methodology

Associate Director, Clinical Operations Resume Examples & Samples

Minimum 5 years industry experience
Experience influencing and negotiating at all levels to achieve team delivery
Proven experience of all aspects of clinical studies including vendor/CRO management, working as part of a clinical development team and coordinating study level activities to deliver data for filing or publication purposes
Experienced in managing global clinical projects, having led the development and implementation of risk management plans, managed study budgets and clinical study resourcing
Experience in working within global organizations
Strong leadership and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies
Demonstrated consistent achievement of team delivery against commitments and goals
Self-motivated and achievement driven
Phase II and Phase III experience
Musculoskeletal
Working collaboratively within global study teams across multiple time zones
Oversee the clinical study protocol development (including amendments) and related documents, in close collaboration with the clinical project lead and other study members
Contribute to scientific and clinical operational input for the development of trial- related documents and processes which are led by other line functions (e.g. Case Report Form)
In collaboration with the clinical project lead, lead development of protocol level feasibility and provide input into other strategic start-up milestones, such as country and site selection
In accordance with the overall program plan, collaborate with Therapeutic Area Project Manager (TAPM) and other line functions to create and manage study specific team goals, milestones, timelines, risk management and quality plans
Establish and maintain detailed day-to-day study level timeline plans
Oversee the development and active management of the study patient recruitment strategies
Ensure study team receives appropriate study specific and therapeutic area training
Lead the team in the identification and selection of vendors and participate in the development, management, and tracking of the vendor budget/contract and performance
Serve as the primary liaison between client and clinical vendors for clinical studies , such as CROs
Accountable for clinical study budgets including forecasting, to ensure efficient expenditure and minimal variance between actual and planned spend
In collaboration with the TAPM, conduct study operational team meetings with input into meeting agendas and review of meeting minutes
In collaboration with the TAPM, lead external meetings such as project kick-off meetings, Investigator Meetings, etc
Manage Investigational Medicinal Product (IMP) supply plan through collaboration with manufacturing and project management
Ensure clinical data are collected and managed in accordance with the study monitoring plan and data quality standards
Oversee the safety reporting processes at clinical study sites and ensures reporting timelines are met
Monitor compliance within the study team to ICH/GCP and SOPs through maintenance and periodic auditing of training files, and through general team member interactions

Associate Director, Clinical Operations Resume Examples & Samples

Develop/implement clinical operational processes and programs to shape working relationships with internal and/or external customers
Set/review/modify/provide input into strategic objectives for applicable clinical operations
Work with internal and/or external customers (e.g., business partners; clinical staff; physicians; facilities owners/operators; health plans) to understand and/or resolve issues (e.g. care delivery issues)
Gather feedback from internal and/or external customers (e.g., business partners; clinical staff; physicians; facilities owners/operators; health plans) regarding clinical operational performance and effectiveness
Work with internal and/or external customers (e.g., national/regional/local focus groups) to identify, define, and/or implement opportunities to improve clinical programs and performance
Meet with internal and/or external business partners regularly to keep them up-to-date on clinical performance and issues to guide decision-making
Remain aware of issues and operations of internal and/or external business partners (e.g., health plans; facilities owners/operators)
Monitor clinical performance metrics (e.g., MEM; quality metrics) to ensure internal and/or external customer and contract obligations are being met
Demonstrate understanding of various operational performance metrics (e.g., medical expense; return on investment; profit and loss; cost targets)
Plan/implement corrective actions/solutions to address operational issues and concerns
Analyze relevant information (e.g., press daily surveys; trends; market needs) to identify potential new programs and services
Examine relevant information (e.g., CMS cost reports) to determine how to expand services
Work with internal partners to determine needed resources and steps (e.g., identify partners; determine ROI; identify staffing needs; create program content) for developing new program/services or expanding existing programs/services
Participate in Quality Assurance activities and audits
Minimum of a Bachelor’s degree required
Minimum of five years operational and clinical experience required
Minimum of 2 years of Leadership experience required
Demonstrate understanding of managed-care entities (e.g., ACO; CCO; HMO) a plus
Demonstrate understanding of relevant clinical practice regulations (e.g., State Board Nursing; Medical/Clinical Practice; Board of Pharmacy; Medical Board of Examiners; CMS)
Demonstrate understanding of state, federal, and private healthcare guidelines, regulations, procedures, and products (e.g., Medicare/Medicaid; HIPAA; MIPAA)
Demonstrate understanding of clinical-related business environment, trends, and issues (e.g., external healthcare systems; market drivers/issues; competitive issues)
Experience working with community based programs and resources designed to aid the Idaho Medicaid population and health care system overall
Demonstrate understanding of internal processes, workflows, policies, and procedures
Demonstrate understanding of tools and systems specific to the business segment
Familiarity with NCQA and URAC standards and organized accreditation review for clinical programs
Experience in developing creative, innovative solution-based programs and initiatives

Associate Director, Clinical Operations Resume Examples & Samples

Continuous evaluation of clinical trial operations processes to identify and address strength and weakness to maintain a competitive advantage
Work effectively with other internal disciplines to enhance the efficiency of the conduct of clinical trials collaborating extensively to obtain functional input on all activities related to initiatives, processes, tools and systems
Ensure clinical studies are conducted according to ICH standards and competent authorities requirements by implementing best practices and strict adherence to GCP process
Ensuring inspection readiness of the Team and the studies
Participate in the selection and cost effective management of external vendors assessing the quality and aligning with the program budgets
Review operational aspects of clinical protocols and provide oversight for trial implementation activities
Overview that study budgets/forecasts and timelines are kept and updated if necessary
Mentor and develop Clinical Operations Managers, Associates and other job roles related to Clinical Operations to expand employee performance levels and assure retention of high performing individuals

Associate Director Clinical Operations Resume Examples & Samples

Master’s in Business, Management, Nursing, Public Health or related field
Senior level management skills with experience developing strategies and leading the administrative and financial operations of a large organization to implement tactical programs in support of the strategies, preferably in a National Cancer Institute-designated cancer center, other large academic clinical research program such as a CTSA, hospital unit, or in an industry-based clinical research organization
Proficiency in Microsoft Office and database applications
Excellent written, verbal, interpersonal, and presentation skills. Ability to communicate effectively with scientific, medical, professional, executives, administrative, and other personnel at all levels of an organization. Ability to build relationships and enable effective communications
Experience with research protocols and regulatory or governing bodies, which include HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies. Additionally, the Associate Director should be familiar with insurance billing, and the Medicare Coverage Act
Demonstrated experience leading and managing staff and/or managers
Demonstrated experience leading multi-site or large-scale clinical trials research
Management experience with developing strategies and leading the administrative and financial operations of a large organization academic or industry-based clinical research organization
Demonstrated ability to interact and influence internal senior leadership and external stakeholders
Demonstrated leadership, planning and change management skills
Demonstrated expertise in project management, analytical problem solving, and negotiating experience
Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies
Demonstrated analytic and critical thinking skills, writing skills, communication skills and consulting skills

Associate Director, Clinical Operations Resume Examples & Samples

Provides functional input and strategic clinical programs input to Clinical Development Team and Program Management Team as required
Has a thorough understanding of the clinical trial(s) protocol(s) and is able to anticipate potential issues that may arise during the conduct of the trial in close collaboration with CROs
Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, guidelines and labeling) to drive the clinical trial application process
Effectively represents the interests and perspectives of Clinical Operations Department
Acts as the main escalation point of contact for strategic CRO for the assigned program and the key stakeholder for clinical operations within the Clinical Development organization
Vendor selection including critical review of contracts, and/or work orders and management of ongoing performance
Collaboration with internal functions to ensure successful implementation of program/study
Conducting study level training
Alignment of program for cross-functional team regarding execution
Works closely with Global Development team, finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies; and ensures finances align with agreed development plan, and budget variances are escalated to management as appropriate
Collaborates on SOP development and harmonization
Identifies or participates in innovative initiatives targeted to improve/revise clinical development processes
Bachelor’s degree is required. Scientific/health care field preferred but not required. Advanced degree preferred
Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical/biotech company or CRO
Global clinical operations research experience is preferred
Experience leading cross-functional teams
Detailed knowledge of current regulatory requirements and guidelines governing clinical research
Participation in investigational new drug and marketing application review and submission is preferred
Experience managing financial budgets is required