Clinical Operations Manager Resume Samples

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C Waelchi

Camille

Waelchi

652 Zackary Locks

Los Angeles

+1 (555) 487 0534

652 Zackary Locks

Los Angeles

Phone

p +1 (555) 487 0534

Experience Experience

Houston, TX

Clinical Operations Manager

Houston, TX

Murphy, Aufderhar and Effertz

Houston, TX

Clinical Operations Manager

Develops a highly motivated team through effective leadership, coaching, and people management, ensuring an objective and performance-led management culture
Working for the Senior Director, Clinical Operations, you will work to develop and grow the capabilities, productivity, quality levels
Assists Director, Clinical Operations to create and deliver new department initiatives, improvement plans or training
Work with key health plan staff on budget development and management of operation for compliance with site budget; including CLIA and liscensure compliance
Provides leadership in CRO bid defense discussions and provide insight and content into contracts and scope of work
Assists Clinical Operations Management with review and revision of departmental SOPs, working practices, and policies
Set performance objectives with the RS staff; provides feedback effectively

San Francisco, CA

Regional Clinical Operations Manager

San Francisco, CA

Eichmann Group

San Francisco, CA

Regional Clinical Operations Manager

May assist in planning and coordinating the efforts of the CRO CRAs/Study Managers in development and evaluation of patient enrolment strategies
Being a Sponsor presence at CA/EC review meetings
Provides a regional point of contact to close out critical issues at site requiring Sponsor input
May provide key country input to Shire study team in the generic assessment of clinical research documents and tools, e.g. monitoring plan, meeting materials/manuals
Partner with key stakeholders internally (listed below) & in country industry networks to improve the performance and quality of clinical trial delivery in their region
Partner with key stakeholders internally & in country industry networks to improve the performance and quality of clinical trial delivery in their region
Provides regional support to Shire study teams to enhance study start up activities in their region – feasibility input for site identification; assists with site motivation as directed by Shire study team

present

Philadelphia, PA

Associate Clinical Operations Manager

Philadelphia, PA

Terry Group

present

Philadelphia, PA

Associate Clinical Operations Manager

present

Training, guiding and mentoring reports
Information: Countrylevel planning timelines, LSR assignments, etc
Responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies
Monitoring activities conducted by clinical investigative sites to ensure successful execution of the protocol
Ensuring regulatory inspection readiness
Drives continuous improvement and simplicity in process and approach and enhances agility
Facilitates Quality Assurance Audit processes as indicated

Education Education

Bachelor’s Degree in Health Care Administration

Georgia State University

Bachelor’s Degree in Health Care Administration

Skills Skills

Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management
Working knowledge of current ICH/GCP guidelines and applicable country specific regulations
Strong communication skills (verbal and written) to express complex ideas
Excellent communication skills, both verbal and written
Excellent interpersonal skills, including negotiation skills
Excellent organizational skills
Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
Good technical background to understand and communicate current and new technologies
Laboratory experience is desirable
Ability to work on multiple projects simultaneously

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Regional Clinical Operations Manager Resume Examples & Samples

Partner with key stakeholders internally (listed below) & in country industry networks to improve the performance and quality of clinical trial delivery in their region
Bachelor’s degree is required
Masters Pharmacy degree, Ph.D. or M.D. preferred. Scientific/healthcare field preferred
Generally has several years of pharmaceutical experience with several years of relevant job experience (clinical trial monitoring required)

Regional Clinical Operations Manager Resume Examples & Samples

Partner with key stakeholders internally & in country industry networks to improve the performance and quality of clinical trial delivery in their region
Country expert for Shire study teams on country regulations and requirements to ensure efficient CA/EC submissions in their region
Will work in partnership with Shire study teams to provide regional oversight of CROs, may include co-monitoring in the regional language; attending the Investigator/Study Coordinator meetings and CRA Training meetings; providing appropriate verbal and written feedback to the Shire study team lead on the CRO monitors regarding performance and corrective actions required
Being a Sponsor presence at CA/EC review meetings
Provide regional support to Shire study teams to enhance study start up activities in their region – feasibility input for site identification; assists with site motivation as directed by Shire study team
Provide a regional point of contact to close out critical issues at site requiring Sponsor input
May provide key country input to Shire study team in the generic assessment of clinical research documents and tools, e.g. monitoring plan, meeting materials/manuals
May assist in planning and coordinating the efforts of the CRO CRAs/Study Managers in development and evaluation of patient enrolment strategies
Responsible for generic review of translated consent and other patient related documents and/or translations for study materials in country-specific language; provides guidance for country specific regulatory requirements/documents and liaise with Shire legal to resolve site contract negotiations/finalization
Responsible for building in-country relationships with our clinical trial investigators & site staff; liaise with site (ideally in regional language) to ensure study teams deliverables are met to time, cost and quality targets
Build a network of experts in new disease areas as required
Manage investigator portal contacts effectively for their region
Act as local Sponsor contact to ensure audit and inspections are conducted professionally observations are evaluated and remediated in conjunction with the Shire study team; ensure ongoing process improvements and/or evaluates all R&D-sponsored clinical trials to ensure compliance with local, state, national and international laws and regulations regarding clinical trials as needed
Responsible for resolving issues in associated regions as directed by Regional Clinical Operations Team Lead
A background in both CRO and Sponsor, Lead CRA/monitoring with international Project Management experience ideally
Understanding of clinical trials and detailed knowledge of GCP/ICH and applicable global regulations
Dual-passport ownership will be an advantage, and the ability to travel throughout these diverse regions (approx. 40%) is essential. Intercultural training and/or experience also an advantage
Excellent organizational, planning, presentation and interpersonal skills. A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach
Excellent communicator, fluent in multiple languages including English, able to define tasks within a project, anticipate and address conflicts in the timely achievement of projects, complete tasks to deadlines and able to prioritize conflicting demands
Someone who is time-aware and able to challenge assumptions in order to optimize timelines, cost and quality
Able to make sound decisions after careful consideration of various courses of action. Someone who considers the impact of those decisions in terms of risk to Shire from a regulatory, legal and business perspective, as well as the short and long-term impacts

Clinical Operations Manager Resume Examples & Samples

Articulate a realistic vision that incorporates continuous operational improvements into daily business practice
Will lead a team of Humana Cares Coaches in measuring, evaluating, and implementing productivity goals
Bachelor’s degree in a health related field OR an Associates degree with an Active Registered Nurse (RN) license
Minimum of 5 years of previous management/supervisor level experience
Progressive business consulting and/or operational leadership experience
Previous experience working in a managed care field
Comprehensive knowledge of Microsoft Office applications to include Word, Excel and PowerPoint
Flexible scheduling availability, with evenings and occasional weekends as business needs dictate
Associates working in the state of Arizona must comply with the Tobacco Free Hiring Policy (see details below under Additional Information) and upon offer will be subjected to nicotine testing as part of a 10-panel drug test
Master’s degree in a health related field
Previous experience in the health insurance industry
Residence within the Central or Eastern Time zone preferred

Clinical Operations Manager Resume Examples & Samples

Will lead a team of Humana At Home Coaches in measuring, evaluating, and implementing productivity goals
Will monitor and identifying challenges with on boarding and provide support with new lines of business and process changes to ensure staff is meeting goals
Minimum in Associates in healthcare, business, or a related field
Previous experience in clinical operations
Able to travel as required for business. Anticipate 10-15% travel annually, though it will vary
Must have a separate room with a locked door that can be used as a home office
Bachelor’s degree in healthcare, business, or a related field preferred
Experience with Special Needs Plans, Dual Eligible, or Medicaid/Medicare
Experience with program development or process improvement

Clinical Operations Manager Resume Examples & Samples

6+ years of pharmaceutical industry experience
4+ years of experience in clinical research
1+ years of line management experience is preferred

Clinical Operations Manager Resume Examples & Samples

Will lead a team of Coaches in measuring, evaluating, and implementing productivity goals
Associates Degree minimum
3 years’ minimum successful demonstrated experience managing leaders in a related field
Successful demonstrated experience in leading teams remotely
Successful demonstrated experience in using data to drive performance
Able to vary schedule to meet business needs which may include evenings and weekends
Bachelor’s or Master degree
Background in healthcare and/or managed care
Participation in continuous improvement initiatives

Clinical Operations Manager Resume Examples & Samples

Develop audit plans and tools for teams to ensure compliance with state contract on performance metrics and to ensure member needs are met
Ensure standard reporting of audits, remediation, of all care coordination processes including trending
Provide oversight of teams conducting audits and other analytical operations to include PIRS, LOCERI, etc. ensuring timeliness and accuracy
Develop reporting tools in collaboration with the Director, Care Management to identify clinical performance
Ensures contract compliance for new member outreach, initiation of services, visit compliance, initial, monthly, quarterly and/or annually
Develop strategies and plans to ensure employee compliance that will include reporting of compliance related issues and any needed improvement strategies
Interviewing, hiring, disciplining, evaluating and mentoring a diverse care coordination work force
Primary responsibility to develop and initiate new employee orientation core curriculums and obtain complete sign-off of orientation tasks list prior to assignment of permanent caseload
Responsible for communication and mentoring members of the care coordination team to ensure long-term and home and community based care guidelines, policies and procedures are followed; provide and/or coordinate staff training for maximum performance and provide developmental opportunities
Monitor performance of staff including service performance and adherence to establish utilization and care coordination benchmarks
In collaboration with the Director, Care Management, develop and monitor development plans for direct reports who need additional coaching in performance area or corrective action plans when warranted
Active participation in the preceptorship of new LTSS clinical staff, providing the level and degree of support needed to ensure that newly assigned CC’s/TC’s are competent in the Care Coordination process
Actively participate in the MAP process, developing annual performance goals, in collaboration with LTSS Director’s for direct reports and monitoring progress on a regular basis
May be assigned a case load of members, when dictated by census fluctuation or staffing coverage
Performs comprehensive member assessment, develops plan of care, risk assessment and all necessary enrollment documents within contractual compliance and provides primary technical support/assistance to subordinates for these job functions
Responsible to lead collaborative calls related to initiation of services
Serves as team’s primary support for technologies, including but not limited to PC/laptop, air care, cell phone, etc.; and,
Develops and maintains an intermediate to advanced functioning in CGX or other Field Service Care documentation system, Word, Excel, Outlook, Visio and other applicable software platforms
Community Well Duals (CW)
Intellectual Disabled (ID)
Developmentally Disabled (DD)
Day Supports (DS)
Technology Waiver (TW)
Aged Blind and Disabled (ABD)
Registered Nurse with active license in the state of Virginia or hold a license in the state of their residence if the state is participating in the Nurse License Compact Law; or master level Social Worker with active license in the state of Virginia (LCSW, LMSW or LAPSW)
2 years of relevant health care experience, preferably in managed and/or long-term care
3 years of experience providing care coordination to persons receiving long-term care and/or home and community based services, Medicare, Medicaid, Duals and/or Special Needs Programs
3 - 5 years supervisory/management experience required
Demonstrated ability to communicate with members with complex medical needs that may have communication barriers
Intermediate to advanced software application and hardware expertise

Clinical Operations Manager Resume Examples & Samples

Effective managing, developing and evaluating the competence and satisfaction of assigned workforce
Effective operational problem solving and communication at all levels
Effective interdisciplinary and interdepartmental collaboration and service coordination
Effective evaluation of departmental practices and process improvement
Effective planning and evaluation of space, resources, numbers and skills of staff to fulfill mission
Licensed to practice registered nursing in the state of WA
Experience in a leadership or teaching role
BSN degree required

Clinical Operations Manager, Onco Apsa Resume Examples & Samples

Support the Cluster GMO Head in development of the Cluster strategy to ensure optimal participation in TCO, OGD and GMA Trials, with alignment with the Cluster medical strategy, Region and Global strategy
Coordinate the Cluster Portfolio management process with input to Region
Support RARMS on the negotiation of bottom up commitment with the CPOs and consolidate Cluster specific contribution and commitments
Main point of contact with APSA countries for resolution of issues before escalation to RARMs and Global clinical trial teams
Coordinate contingency plans with the CPOs within the Cluster to maintain commitment (both patient and timelines) negotiated with Region. Communicate action plans to RARMs when timelines are at risk
Report on Cluster performance status (country performance, trials, monitoring, gaps, quality, sites performance) to APSA regional Office. Responsible generating for monthly reports
Collaborate with Cluster, GMO heads and Country MDs for use of efficiencies and productivity. Provide guidance and share best practices across the Cluster as needed
Strengthen the collaboration with TCO Shanghai for further participation in TCO studies
Identify gaps and support on the identification and qualification of new TCO sites when needed
Support the conduct of Regional Medical Investigator’s meetings from an operational perspective as needed

Associate Clinical Operations Manager Resume Examples & Samples

Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity
The Associate Clinical Operations Manager (ACOM) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues)
Additionally, the ACOM may train and provide guidance to junior staff
In the country/region based, may manage up to 6 SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies
Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to (Sr) SCRAs
Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members
Appropriately reports and escalates serious or outstanding issues to project team member(s) and/or Senior ACOM/ COM/ Sr COM as appropriate, as defined in the study monitoring plan
Facilitates Quality Assurance Audit processes as indicated
Ensures regulatory inspection readiness at assigned clinical sites
Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline by enhancing the enrollment schedule of clinical investigative sites
Reviews monitoring visit reports for assigned CRA's. May act as back-up or secondary reviewer for other countries as required
Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner
Participates in field training and mentoring of new/junior SCRAs as well as insourced SCRAs. May provide input relative to performance review and development opportunities
Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met
Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up
May coordinate local SCRA team working on the same projects, when applicable
Supports remote monitoring, if and as applicable
Employs excellent financial management to conserve costs of departmental operation and controls travel expenses, with guidance from Senior ACOM/ COM/ Sr COM as appropriate
Provides hands-on assistance to assigned staff for project implementation as needed. Where appropriate, monitors project progress against time frame and budget. Informs the Clinical Operations Manager and/or the Senior Clinical Operations Manager of any variance
Supports the Clinical Operations Manager and/or Senior Clinical Operations Manager in ensuring that globally accepted compliance standards are met in the country based, and that quality standards in the conduct of clinical research are maintained
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and to quality standards in conducting clinical research
Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders
Maintain and complete own expense reports as per local and applicable guidelines
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators
Participates in and/or presents at departmental and other functional meetings as needed, including Site Management & Monitoring meetings
Participates in special projects/work groups
Identifies and partners with other AbbVie personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations while conserving overall departmental operating costs
Maintains knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities
Creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels
Maintains appropriate communication with relevant functional areas
Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes

Clinical Operations Manager Resume Examples & Samples

Complete DOCS induction and orientation for newly employed staff
Ensure client-specific induction and orientation is planned, communicated and completed
Establish goals and objectives for each staff member
Monitor performance and conduct annual appraisal
Conduct regular 1:1 meetings
Ensure timely submission and approval of time reports, expense reports and leave requests
Manage non-rechargeable expenses for assigned employee, per regional guidelines
Create a positive relationship between DOCS, the employee and the client to ensure retention
Conduct accompanied site visits, if applicable / approved
Ensure timely identification, resolution and escalation of issues
Implement, monitor and ensure appropriate completion of a Corrective Action Plan, if required
Establish routine teleconference and meeting schedule with client contact(s) to effectively manage client relationship
Obtain regular client feedback to ensure staff is meeting performance expectations and PDPs are aligned with client goals
Agree Key Performance Indicators (KPIs) with client and periodically review results
Ensure compliance with time and expense reporting requirements of client contracts
Collaborate with client to forecast resource requirements
Ensure DOCS understands current client procedures and expectations
Proactively plan for contract extensions, completions and terminations in collaboration with client and relevant DOCS departments
Minimum of five (5) years of relevant industry experience
Minimum of three (3) years of line management experience for Operations Manager position
Greater than three (3) years of management experience for Senior Operations Manager position
Ability to liaise successfully with clients, staff and other departments
Demonstrated ability to identify, analyze and solve problems
Excellent interpersonal, organizational and management skills
Excellent verbal and written communication skills in English and local language
Ability to operate in a multi-cultural environment
Due to the nature of the position, the employee may be required to travel. Therefore, dependent on the employee’s location, a valid driver’s license will be required
This position will be office-based or home-based depending on the regional structure
LI-LK1*

Clinical Operations Manager Resume Examples & Samples

Is responsible for all appropriate documentation and reporting requirements, such as QA reports, performance evaluations, time sheets, and budget variance reports
Ensures the appropriate level and mix of staff and effective staff utilization to meet staffing and workload requirements and support the delivery of quality patient care and services, within budgetary guidelines
Works with Human Resources staff to recruit and hire staff; and coordinates comprehensive orientation of new staff
Establishes performance goals and provides counseling, coaching, feedback, recognition, training and development to staff
Collaborates with physician managers and providers to coordinate day-to-day patient care, ensure balanced provider panels within the health care team, and facilitate appointment access for members
Five (5) years of current clinical experience plus two (2) years of supervisory experience required

Clinical Operations Manager Resume Examples & Samples

Provide leadership and oversight for clinical study operations world-wide
Establish mechanisms to track and report 3M’s global clinical research activities and impact
Ensure that OUS clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
Propagate necessary policies and procedures to ensure compliance
Collaborate with division clinical managers to develop clinical studies to support division’s priorities and businesses
Bachelor's degree or higher from an accredited institution
Minimum of ten (10) years of pharmaceutical, medical device and/or academic health care experience
Minimum of ten (10) years pre-clinical and/or clinical research experience
Master’s degree or higher in a Science discipline from an accredited institution
Minimum of five (5) years of medical device experience
Experience with new product development programs
Experience working with customers in understanding/documenting voice of customer and user requirements
Proven process improvement experience such as Six Sigma
Strong communication skills and a demonstrated ability to work collaboratively with multiple functions and organizations
Strong leadership and team building skills
3M experience working across multiple disciplines, businesses and/or departments (applies to internal applicants only)
Excellent communications skills (oral, written and presentation)

Clinical Operations Manager Resume Examples & Samples

Minimum of six (6) years of clinical research experience, with at least four (4) years of relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least two (2) years as a Project Manager, CRA Manager or equivalent job role
Fundamental knowledge of Clinical Research, and expertise in all phases of a clinical trial
LI-LG1

Clinical Operations Manager Resume Examples & Samples

Bachelor Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
Five to seven years clinical research experience
Extensive experience in clinical project management and coordination
Expertise in core clinical, regulatory and financial systems, tools and metrics
Extensive knowledge of local regulatory environment and submission and approval processes
Strong negotiation skills as well as excellent influencing and training/mentoring skills both written and verbal
Ability to focus on multiple deliverables and protocols simultaneously is essential
Ability to work effectively, also in a remote virtual environment, with a wide range of people
Strong coordination and organizational skills
Has demonstrated the following leadership behaviors: Ethics & Integrity, Focus on Customers, Drive Results, Collaborate
Language requirements: Bilingual (French and English)

Clinical Operations Manager Resume Examples & Samples

Assists in the development and implementation of CA Division Pharmacy strategies in the clinical management of pharmaceuticals. Assist in the planning, development and implementation of Ambulatory Care Pharmacy Services, Drug Education and Drug Use Management, and Oncology services/programs for an entire Service Area or assigned area within a Service Area (including Outside Networks). Develops and implements pharmaceutical care programs to enhance quality, improve member service and enhance cost effectiveness. Provides leadership and direction to staff including hiring, evaluating and coaching. Develops a team of professionals who plan and implement goals and objectives. Administers all departmental policies and procedures. Provides leadership in the development and implementation of capital and operating budgets. Ensures that Am Care and Drug Education activities integrate with Service Area and CA Division Pharmacy Services Business Plan. Accountable for fiscal outcomes. Management of Oncology Services may include oversight of licensed Oncology pharmacies (may include Outpatient, Inpatient, Sterile Compounding and The Joint
Minimum three (3) years of experience providing functional / clinical direction in an in- or out-patient pharmacy required
Minimum three (3) years of management experience in an ambulatory pharmacy preferred

Clinical Operations Manager Resume Examples & Samples

Guide training and development of RS staff in an effort to ensure they have the necessary skills to deliver on ICON’s standards, targets and expectations
Set performance objectives with the RS staff; provides feedback effectively
Identify areas of personal strength and areas for further development of RS staff
Liaise with internal and external clients on RS related matters, as necessary
As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
Ensure appropriate issue escalation of findings related to the quality of performance of monitoring or site management activities
Provide feedback on the development and implementation of formal CRA/SMA training tools and presentations
Implement agreed corrective actions and/or further training as required
Conduct timely performance reviews and appraisals for assigned RS staff. Ensure clear goals are set
Bachelor’s degree, or local equivalent, in medicine, science or related discipline
Proven experience of managing monitors (in-house and in-field) effectively
Experience in a health care and/or research environment preferred
Fundamental knowledge of Clinical Research, and expertise in all phases of a clinical trial, Late Phase experience strongly preferred
Previous experience in delivering training
Ability to liaise successfully with clinical project teams and other relevant departments, at all levels
Excellent written and oral skills
Excellent written and spoken English
Good cross cultural sensitivity
Understands team dynamics, processes and development
Foreign language skills desirable
Due to nature of this position, the employee will be required to travel. Travel (approximately 25%) domestic and/or international

Assocaite Clinical Operations Manager Resume Examples & Samples

Supports the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US) I region (US) of responsibility
Gives support in providing ongoing assessment of resource needs and in allocating resources in alignment with AbbVie's research goals, priorities and specific study timelines. Identifies and communicates issues that impact resource allocation and provides solutions
For direct reports, ensures clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives. Anticipates and identifies site issues that could affect timelines and develops alternative solutions
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to

Clinical Operations Manager Resume Examples & Samples

Under supervision of Sr. Director of Clinical Affairs CDx, works with relevant departments (R&D, Regulatory Affairs, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms
With minimum supervision, completes all operational activities related to in vitro diagnostic device clinical trials: site selection, contracting, site initiation, study conduct and close-out
Schedules and completes on-site monitoring visits to ensure protocol compliance and accuracy and completeness of clinical data
Communicates with study investigators in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials
Negotiates site-specific study budgets, initiates and oversees contract origination, compliance approval, and execution. Completes the tracking of budgets for studies
Leads the organization, preparation, implementation and completion of clinical studies according to FDA standards and Good Clinical Practice (GCP). Provides technical training and monitoring; coordinates daily activities of trial sites
Educates and assists sites to ensure timely completion of study
Responsible for the assessment of complications and serious adverse events. Including reviewing and reconciling data and documentation related to the event
Conducts quality control to ensure compliance to the study protocol, trial material storage and accountability
Coordinates IRB submissions, addendums and renewals
Liaison among clinical site staff, biopharmaceutical company personnel and internal stakeholders (R&D, Regulatory Affairs, Quality Assurance, etc.) to ensure xxx
Supports regulatory submissions by contributing and submitting necessary clinical data and study reports
Responsible for up-to-date clinical study progress reports
Represents Clinical Affairs on cross-functional teams to support diagnostic development
The qualified candidate must have BA/BS or equivalent; advance degree preferred; five years related experience (Clinical Operations) and/or training; or equivalent combination of education and experience
GCP Trained
Experience with in vitro diagnostic industry and products preferred
Excellent interpersonal skills, including negotiation skills
Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
Good technical background to understand and communicate current and new technologies
Laboratory experience is desirable
Must be able to work within constraints of time and budget

Clinical Operations Manager, Study Start Resume Examples & Samples

5-7 years’ clinical research experience
Fluency in English, French and/or Dutch
Extensive knowledge of Belgian regulatory environment and submission and approval processes
Strong negotiation skills as well as excellent influencing and training/mentoring skills
Ability to work effectively also in a remote virtual environment with a wide range of people

Area Clinical Operations Manager Resume Examples & Samples

Bachelor’s Degree in Nursing or the equivalent
A minimum of eight years clinical experience including two years in home care environment generally required
Current RN licensure in the state of practice plus strong knowledge of home health operations/regulations required
Must have board knowledge of home health agency regulatory requirements and administration
Excellent proactive leadership skills, strong verbal/written communication and interpersonal skills

Clinical Operations Manager Resume Examples & Samples

Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
Minimum of five (5) years relevant clinical research experience in a pharmaceutical company/CRO
Thorough knowledge of drug development process
Thorough knowledge of relevant SOPs, ICH, and GCP guidelines
Relevant supervisory experience
Minimum of 1 year as a Line Manager or Project Manager required
Demonstrated ability to lead by example and to encourage team members to seek solutions
Proven interpersonal skills
Demonstrated ability to successfully participate as a member of a project team
Demonstrated ability to successfully manage multiple competing priorities
Excellent oral, written and presentation skills

Associate Clinical Operations Manager Resume Examples & Samples

Monitoring activities conducted by clinical investigative sites to ensure successful execution of the protocol
Conducting monitoring visits to ensure AbbVie studies are conducted according to all applicable regulations and business processes
Ensuring regulatory inspection readiness
Training, guiding and mentoring reports
Responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies
Supporting the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within the UK
Degree qualified or equivalent experience - ideally in a lifescience or healthcare discipline
Substantial clinical related experience, with proven experience as clinical research monitor
Proven experience working with EDC, clinical trials management systems and other computer based packages
Expert knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations
Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired
Proven strong site management and monitoring skills
Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
Attention to detail and strong interpersonal skills
Ideally knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials

Clinical Operations Manager Resume Examples & Samples

Fully support and contribute to the operational goals and mission of the research organization
Directly manage up to 3 Coordinator Supervisors, a Lab Manager, the lead QA Coordinator, and a Regulatory Coordinator
Assess and improve as required the productivity, professionalism, and quality of work of the clinical operations staff
Encourage and emphasize a robust customer service approach to our pharmaceutical clients and the research volunteers
Advise on research staff training programs
Facilitate open and productive communication between the Sponsors, CROs, other study vendors, study volunteers, the operational staff, the recruitment staff, and ownership
Provide logistical oversite for study start-up, with special attention to trial timelines, resource allocation, and maximizing study enrollment
Provide input on resourcing needs based on research pipeline opportunities
Lead and manage development efforts and relationships with new or existing investigators and other area healthcare entities. (ie: imaging centers, local labs, GI centers, etc..)

Clinical Operations Manager Resume Examples & Samples

You will be responsible for the coordination, execution, control and completion of the Clinical Operations at country level
Ensuring delivery and development of the Clinical Operations team against key metrics
Drive the completion and delivery of the end to end service through a variety of metrics and KPIs enabling
ICON develops and grows the delivery of work at country level
Working for the Senior Director, Clinical Operations, you will work to develop and grow the capabilities, productivity, quality levels
Provide direction and accountability for the operational teams and their delivery at the country and site level
You will have had a successful career within the CRO/Pharmaceutical industry at Senior Associate and/or manager level
Excellent management skills, developed with a collaborative approach to driving performance and success in the global environment
In depth proven experience as a Senior CRA or Principal CRA (in a Lead CRA role), Project Manager, CRA Manager, SSU Manager or equivalent job role

Clinical Operations Manager Resume Examples & Samples

Line management for assigned CTMs, Lead CRAs and CRAs (both office and regionally based) in the following areas
Assists Clinical Operations Management with review and revision of departmental SOPs, working practices, and policies
Assists Clinical Operations Management with interviewing and making hiring recommendations and/or decisions on new staff
Communicates staff increase and equipment needs to Director, Clinical Operations
Communicates staff training needs to Director, Clinical Operations
Assists Director, Clinical Operations to create and deliver new department initiatives, improvement plans or training
Assists Director, Clinical Operations with development of strategic departmental goals which correlate with corporate goals, and formalize departmental action plans to meet those goals
Assists in developing department budget and is accountable for the profit/loss and the overall financial performance of the Clinical department
Assists Director, Clinical Operations with Process Improvement Plans and other special projects as required by the department
Provides clinical management oversight of clinical projects to ensure consistent on-time completion of client deliverables and timely escalation and resolution of issues
Collaborates with other department and/or functional groups to ensure consistency of processes
May serve as CTM for projects as directed
Assists CTMs with defining the scope of work with the clinical monitoring team
Assists CTMs with identifying changes in scope
Provides vacation coverage for CTMs as required
Provides clinical expertise to project team as needed
Participate in the development of the clinical portion of client proposals including preparation of clinical project budget and text
Preparation for and attendance at capabilities and bid defense meetings
Participate in marketing activities, client presentations, and proposal development
Participate in and/or attend professional and industry meetings as a representative of Novella
Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management
Strong communication skills (verbal and written) to express complex ideas
Positive attitude and ability to interact with all levels of staff
Ability to balance needs of the organization with needs of staff
Ability to protect confidential/sensitive information
Ability to manage multiple priorities within the department and across staff
Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
Ability to mentor and train clinical staff
Understanding of basic data processing functions, including electronic data capture
Working knowledge of Word, Excel, and Power Point
Working knowledge of current ICH/GCP guidelines and applicable country specific regulations
Able to qualify for a major credit card
Valid driver’s license; ability to rent automobile
Ability to travel domestically and internationally up to 40%

Senior Associate Clinical Operations Manager Baltic States Resume Examples & Samples

Line Manager for clinical staff responsible for investigator site management & monitoring in a country
Manages/oversee site related activities as they relate to Abbvie clinical studies
On-time and within budget execution of all clinical trials within a country
Resource planning and allocation
Functional budget planning and administration
Ensures adherence to applicable regulations, ICH GCP, AbbVie SOPs and quality standards
Ensures health authority inspection-readiness at all times

Associate Clinical Operations Manager Resume Examples & Samples

Accountable for all activities of site related study execution of assigned studies / Monitors involving start-up, execution, and close-out. Accountable for the on-time and within budget study execution of assigned projects, including but not limiting to country and site feasibility
Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country / district, and provide impact analysis of significant changes affecting conduct of Clinical studies
Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation
Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions
Responsible for the acquisition and retention, performance management, and growth and development of talent. May be responsible for being the country point of contact for CROs for an assigned study / studies. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager
If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating "lessons learned" across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner
If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc
If assigned; Global Representative for single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials
If assigned; Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies. Responsible for the direct/functional management, as applicable, of the assigned Remote Monitors including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development
Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
Site Monitoring Experience: Minimum 3 years
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player
Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading(within country) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases
Drives continuous improvement and simplicity in process and approach and enhances agility

Clinical Operations Manager Resume Examples & Samples

Monthly calculation of MSA KPIs and metrics based on several sources (e.g. masterfile, excel-sheets etc.), tracking, analysis, interpretation and strategic proposals for improvements/risk mitigation
Development, implementation and tracking of new KPIs based on the MSA strategy in close cooperation with key stakeholders
Quarterly preparation of the MSA Balanced Score Card, analysis and interpretation
Preparation of management reports (e.g. working hours report, MSA Management Report), continuous improvements based on management requirements; creation, analysis and interpretation of ad hoc reports from various sources (e.g. internal databases) for management use
Budget tracking and oversight: project management tool planning of MSA Core activities together with finance, monthly tracking of the MSA budget, preparation of customized finance reports for study managers; analysis, risk identification, proposals for corrective actions, primary point of contact for finance
CPS super user/business liaison manager for Diagnostics IT systems like clinical trial manager system, study registry, eTMF: key contact person for IT in case of global change requests, forward and discuss CPS change requests to IT; training and first-level support of CPS MSA employees
Owner of MSA own IT tools (like Masterfile, Resource allocation and planning): governance and continuous improvements of the tools based on business needs, training and first-level support of CPS MSA employees

Clinical Operations Manager Periop Services Resume Examples & Samples

Manages clinical operations, including staffing schedules, phone access to the health care team, and patient flow
Minimum five (5) years of current clinical experience plus two (2) years of supervisory experience required
Endoscopy, PACU and Sedation experience preferred. Competent in reprocessing endoscopy scopes

Associate Clinical Operations Manager Resume Examples & Samples

Supports the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US) / region (US) of responsibility
Bachelor’s Degree required; medical/science/nursing background is preferred
Expert knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English)
Acute observational skills, analytical and conceptual capabilities

Clinical Operations Manager Resume Examples & Samples

0 Weekly
0 Monthly
0 Annually
Speaking: Yes - English and Local Language required
Writing/Reading: Yes - English and Local Language required

Manager, Clinical Operations Manager Resume Examples & Samples

Role functions as the process and country subject matter expert guiding the standard of conduct for; Site Budgets & Contracts
Supports Clinical Research Director and vendor partners in providing oversight for Clinical Operations Managers (COMs) within the country
Point of escalation for budget and contracts for site and country related issues
Coordinates and liaises with Clinical Research Managers, Clinical Trial Coordinators, CRAs (Finance and legal if appropriate) to ensure country deliverables are obtained for budgets, contracts and local milestones
Oversees COMs as appropriate by partnering with vendor partners to assure operational oversight for the COMs deliverables and project assignments
Responsible for managing country deliverable as it relates to financial aspects of the clinical trial
Responsible for the development of the local SOPs, checklists, and job aids
Works closely with the Clinical Research Managers within the country for site initiation strategy
Strong knowledge of regulatory and/or budget and contract regulations (FDA/ICH/GCP)
Works closely with Clinical Research Director and local GCTO country operations to assess, prioritize, and drive execution of clinical trials in order to support and manage the pipeline and local business needs to agreed upon timelines and budgets
*This position is Remote-Based anywhere in the US***
A minimum of 8 years of clinical research experience
Extensive experience in clinical research operations and experience with project management and coordination
Knowledge and experience of core clinical, regulatory, and financial systems
Ability to work remotely

Clinical Operations Manager Resume Examples & Samples

Working for the Director/Senior Director, Clinical Operations/or the VP Clinical Operations you will work to develop and grow the capabilities, productivity, quality levels
With a University degree in medicine, science, or equivalent, you will have had a successful career within the CRO/Pharmaceutical industry at Senior Associate and/or manager level
At least 2 years of direct line management experience whiten the Clinical Operations area
In depth proven experience as a Senior CRA and SSU activities
Fluent in both English and German

Clinical Operations Manager Resume Examples & Samples

5+ years of significant level of relevant work experience, including team leadership experience, required
Responsible for the day to day operational management of Cummins on-site and near site health centers
Includes the tracking of all health center related issues while working collaboratively with the operating vendor
Work with the Cummins Clinical Operations team in developing and maintaining the High
Performance Network
This position will report to the Clinical Operations Director
College, university, or equivalent degree required

Clinical Operations Manager Resume Examples & Samples

Directly monitors patient throughput in real time to ensure effectiveness, efficiency and safety are priorities in moving patients through their clinical visits. Makes on the spot adjustments to improve throughput when necessary
Works with the clinical leadership and other key departmental clinical/administrative staff on matters relating to practice performance and clinical issues in accordance with budget, goals and benchmarks. Provides leadership and direction to clinical staff where appropriate
Researches and develops proposals for internal and external program initiatives and new administrative and clinical opportunities and advises leadership on the impact of new projects or initiatives. Prepares special analyses, reports and complex modeling to support the decision-making process. Analyzes proposals and determines cost, benefits, risks and liabilities
Streamlines communications between EMR, team, physicians, and clinical staff. Establishes, implements and monitors medical record protocols and procedures. Ensures office compliance with Federal/state/local regulations
Monitors clinician work schedule assignments for best utilization of space, maximum productivity, and adherence to clinic session guidelines. Builds templates and performs maintenance on schedules as necessary
Represents area with regard to facility concerns, maintenance and security
Keeps current in clinical management and process improvement concepts through involvement in professional organizations, seminar attendance, user group meetings and individual research

Clinical Operations Manager, Nicu Resume Examples & Samples

2 years of experience in management/administration
Advanced education in business, management, or related field
Experience in management in a healthcare setting
Pediatric Advanced Life Support (PALS) or Pediatric Emergency Assessment Recognition and Stabilization (PEARS) (check department-specific recommendation)
Must possess excellent communication, organization, and interpersonal skills
Team partnering
Conflict resolution
Problem-solving
Listening
Staff development
Time management
Physician relations
Fiscal management
Must be able to successfully pass the Basic Windows Skills Assessment at 80% or higher rating within 30 days of employment
Attends educational opportunities of minimum 18 hours job-related education per year
Fosters professional development of others via constructive performance appraisals and professional development plans
Establishes sound CHOICE council structure for units of accountability
Fosters collegial relationships between team members, other departments, and medical staff members
Establishes departmental goals and leads unit to achieve them
Manages staffing effectiveness
Rounds proactively throughout unit to identify and react to escalating concerns of potential or actual conflict, seeking resolution and incorporating service recovery
Develops and maintains relationships with leadership in other departments to ensure appropriate resources are accessible for clinicians
Executes implementation plans for system and unit changes
Engages departmental leaders to achieve unit goals and projects
Focuses time and attention on key retention activities
Coaches staff to improve performance
Understands CAN program and educates Assistant Nurse Managers and staff
Provides oversight for development of quality measures and quality controls for unit
Ensures compliance with all regulatory requirements, including Joint Commission
Leads unit in creation of staffing effectiveness monitors
Oversees follow-up to occurrence notification system reports
Participates in departmental assessment of national recognition data collection processes
Allocates resources to work toward care standardization and performance improvement in accordance with evidence-based practice

Clinical Operations Manager, Orange County Resume Examples & Samples

Minimum of 2 years' experience in dialysis preferred
California RN License required in certain markets
Current CPR certification required (or certification obtained within 60 days of hire)

Clinical Operations Manager Resume Examples & Samples

BS plus 7 years OR MS plus 5 years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on drug development and project management, ideally in a multidisciplinary environment
Superior interpersonal skills and expert team player with demonstrated ability to build collaborative relationships at all levels inside and outside of the organization, specifically with line management staff and with management at all levels in partner vendor organizations
Superior negotiation skills
Demonstrated experience managing multiple strategic partnerships
Solid knowledge of drug development process; preferably of vaccines development

Clinical Operations Manager Resume Examples & Samples

Bachelor's Degree (or comparable) / Life Science or equivalent Health Care related experience
3-7 years clinical research experience
Expertise of core clinical, regulatory and financial systems, tools and metrics
Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
The ability to focus on multiple deliverables and protocols simultaneously is essential
Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures
Fluency in English

Clinical Operations Manager Resume Examples & Samples

Oversee Clinical Research Associate (CRA) and all associated monitoring activities
Provide leadership and oversight to Clinical Research Organizations (CROs) ensuring compliance to responsibilities as outlined in the transfer of obligations and in accordance with CRO and sponsor policies, procedures, SOPs, ICH/GCP guidelines
Participate in the identification and evaluation of new CROs as it relates to monitoring activities
Provides leadership in CRO bid defense discussions and provide insight and content into contracts and scope of work
Implement the oversight and monitoring strategy and associated systems. Ensure individual CRAs and LCRA/CTLs are fulfilling monitoring requirements and meeting project and Kite timelines put in place to support the clinical deliverables of projects
Develop CRA training curriculum and study plans (including clinical monitoring plans, corrective action plans, and study training materials). Co-ordinate and preform CRA training and provide continuous update training as needed to support evolving study needs
Assess resourcing and CRAs workload and lead the interview, site assignment, and transition of work processes to new CRAs as applicable
Serves as the Kite single point of contact to the CRO for monitoring activities. When monitoring issues are identified, proactively discuss with clinical teams
Participate in issue escalation and governance committees for CROs, vendors, and partners
Develop risk based approach to review monitoring reports and conduct co-monitoring CRA assessment visits as applicable
Partners with senior leadership, and other applicable departments, in the development, review and implementation of departmental SOPs, business improvement / innovation initiatives
Develop and implement QMS for monitoring activities and create metrics, key quality and performance indicators. Leverages analytics to perform trend analysis of monitoring data and identify gaps in performance and quality
Report out metrics to Sr. Management and proactively identify issues and recommend opportunities to improve quality, compliance, and efficiency
Lead audit and inspection readiness in the monitoring function and development of root cause analysis and CAPA in response to internal audits and inspection by health authority agencies
Evaluate the evolving clinical research operations environment and competitive landscape, generates ideas and recommendations, and participates in quality assurance activities that foster continuous improvement across clinical monitoring process

Clinical Operations Manager Resume Examples & Samples

Provides guidance to clinical team members regarding practice, serves as a resource, and mentor. Leadership skills demonstrated in decision making and problem solving. Serves as Subject Matter Expert for Electronic Heath Record (EHR)
Collaborates with physicians regarding clinical aspects of patient care in an effort to ensure the provision of high quality health care services
Develops positive relationships between the Physician Group and community agencies, special interest and civic groups, and professional affiliations by acting as a Physician Group representative
Evaluates performance and implements changes that increase the efficiency and clinical effectiveness of the Physician Practice. Keeps administration informed of activities, needs, and opportunities in order to promote operational efficiency. Continually monitors the functioning of the clinics and recommends revisions as needed
Provides guidance and support to Leaders, Providers, and staff as necessary. Assists with development and implementation of clinical staff competency and evaluation of performance through team member training techniques needs assessment. Assists with the interviewing, selecting, training and orienting of clinical staff ensuring efficiency and clinical effectiveness. Assists with the counseling of clinical staff as needed
Ensures patient care is delivered in a safe manner consistent with health promotion. Develops and implements a system to ensure that established policies, goals and objectives are achieved through direct observation, action plans, intervention if necessary and accountability
Utilizes the quality process and best practices to improve clinical operations. Utilizes guidelines, standards and research to support a care delivery system promoting quality patient care with optimal patient outcomes. Incorporates data and information and uses evidence-based practices and research to continually improve clinical operations
5 years of clinical experience as a Registered Nurse

Clinical Operations Manager Resume Examples & Samples

Works with the practices and the management team to develop and implement long and short range business plans for practices. Meets regularly with the appropriate clinical leaders in each practice
Analyzes information, develops strategies to improve operations and enhance service delivery; implements changes in conjunction with and advise from the management team. Acts as the liaison with other hospital departments to resolve problems that interfere with the efficient operation of the practices
Develops practice performance standards in conjunction with the management team. Monitors practice performance regularly against those standards and prepares and implements steps to bring the practice into conformance with those standards. Develops management reports to measure provider productivity, assesses patient demand for services, determines patient satisfaction and otherwise evaluates the effectiveness of the practices’ operations. Develops and implements cost-effective operational adjustments as appropriate to enhance practice efficiency
Controls purchase and distribution of supplies in the practices. Establishes and maintains inventory system of supplies. Works with providers and vendors to procure cost-effective purchases and provide inventory control
Attends management meetings, and participates in other hospital committees as required. Complies with BMC managerial expectations, such as regular attendance at managers’ meetings, safety training, annual diversity training, etc
Calls, prepares agenda for, and participates in monthly meetings with all practice personnel, in consultation with the management team. Prepares follow-up work plans to items discussed at the practice meetings, and monitors completion of identified projects and tasks. Communicates BMC and/or practice priorities and essential information to staff on a regular basis
Participates in practices’ and hospital-wide quality assurance activities. Leads practices, efforts in continuous quality improvement by involvement in teams as appropriate and by supporting changes recommended through the continuous improvement process. Participates in establishing and implementing quality assurance standards
Bachelor's Degree or equivalent plus 5 years of related experience (will consider equivalent combination of formal education and experience, i.e. HS/GED plus 9 years related experience or Associates plus 7 years related experience)
Requires a minimum of 5 - 7 years in a hospital or healthcare setting with prior experience of healthcare finance, professional billing and practice management
Three (3) years previous clinical, supervisory, and budget experience required
Ability to work collaboratively in medical matrix team, and the ability to adequately represent needs of medical services, and work with multiple physicians of numerous specialties
Comprehensive knowledge of clinical operations, hospital financial and human resources policies and procedures
Excellent understanding of hospital and physician reimbursement as well as applicable external regulations and legal requirements
Outstanding interpersonal relationship building skills; ability to mentor, guide and motivate direct reports through demonstration of best practices and leading by example
Able to prioritize and manage multiple projects simultaneously and produce expected results
Highly developed skills using personal computer tools including computerized healthcare information system, word processing, spreadsheets and presentation applications
Demonstrated critical thinking, analytical and problem-solving skills

Clinical Operations Manager Resume Examples & Samples

Strong knowledge base of the purpose of the LivingWell and what services are offered
Proficient in the current HEDIS/P4Q/Stars measures and understanding of how a Medicare Advantage plan works
Adheres to HIPAA guidelines and maintains confidentiality
Maintains a positive professional relationship with the staff, referring providers, community groups, the health plan and enterprise teams
Be available to patients for any questions or concerns that occur in the clinic
Hire and Build a high quality clinical and service-oriented team
Manage/oversee daily operations of a multi-disciplinary team; which includes scheduling/registration, clinic flow, documentation, and patient satisfaction
Analyze clinic workflow/efficiency and develop action plan for changes; where needed
Print and review reports that identify visit numbers, open orders, reporting trends and patterns to identify opportunities for improvement
Develop good core relationships with oversight physician and referring providers to drive volume
Oversee the daily schedules to ensure that visit times are being booked and utilized to capacity
Overall direction/coordination/evaluation of site
Interview, hire, train employees, monitor and evaluate staff performance and rewarding/disciplining employees
Know and adhere to all Policies and Procedures established by HealthSpring
Work with staff to develop/implement ideas for higher quality and cost effective services
Review/monitor staffing levels/productivity
Conduct monthly employee staff meetings
Ensure that the facility is clean, maintenance is done in a timely manner and the area is safe
Keep a log of equipment and ensure it is in good working order
Work with key health plan staff on budget development and management of operation for compliance with site budget; including CLIA and liscensure compliance
Facilitates compliance with local/federal regulations and corporate Standard Operating Procedures
Develops action plan if deviation from compliance policies
Implement/maintain OSHA compliance, training, and policies/procedures
Maintain employee files, professional licenses/affiliations for sites, control overtime, evaluate/educate needs of staff
Conduct ongoing clinical training according to HealthSpring policy and individual clinic needs
Attend all mandated meeting and disseminate the information to clinical staff, when directed
LPN, LVN, RN or BA in health related field or business administration required
7+ years experience in case management, medical management, utilization management OR healthcare operations with 3+ years of management of clinical staff
Organizational initiatives
Experience in application of business principles to clinical practice

Clinical Operations Manager Resume Examples & Samples

Complete DOCS induction and orientation for newly employees
Establish goals and objectives for each employee
Monitor performance and conduct annual appraisal for each direct report, as applicable
Manage non-rechargeable expenses for assigned staff, per regional guidelines
Create a positive relationship between DOCS and the client to ensure retention
Monitor and update relevant CPC data in OMNI
Obtain regular client feedback to ensure direct reports are meeting performance expectations and PDPs are aligned with client goals
Ability to liaise successfully with clients, direct reports and other departments
LI-AC1

Associate Clinical Operations Manager Resume Examples & Samples

Accountable for all activities of site related study execution of assigned studies / Monitors involving startup, execution, and closeout. Accountable for the ontime and within budget study execution of assigned projects, including but not limiting to country and site feasibility
Ensure audit and inspection readiness of assigned sites. Advise on preaudit
Activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation
If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with countrylevel
Information: Countrylevel planning timelines, LSR assignments, etc

Clinical Operations Manager Resume Examples & Samples

Five plus years post-masters clinical experience
Masters prepared in a Health Sciences field
Knowledge of health advocacy and wellness programming, protocols, trends and philosophy
Knowledge of clinical care management programs and services
Must be familiar with quality management principles and processes
Experience in a managed care environment
Proven track record of strong leadership, team-building experience, and demonstrated decision-making abilities
Experience in strategic planning and business development
Demonstrated ability to motivate, develop, and coach employees
Experience in analyzing & reporting on utilization management and unit cost trends
Knowledge of current theory and practice in mental health/substance abuse treatment and care management
Demonstrated skills in customer service, leadership, decision-making, and oral and written communication
Demonstrated ability to understand and effectively relate to employees at all levels
Maintains and enthusiastically portrays an optimum level of conscientiousness for the growth and profit of Cigna

Clinical Operations Manager Resume Examples & Samples

Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented
Ensures training record compliance with training matrix and ensures training records are up to date
Assist with coordination and implementation of on-boarding new direct reports ensuring GCP training before monitoring begins
Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level
Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers and assists management team for mitigation
Escalates available workload hours, in context of project allocation, supply and demand, to management team
Assist with staff recruitment through screening and interviewing
Financial authority in accordance with current signature approval matrix
Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma
Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget

Clinical Operations Manager Resume Examples & Samples

Strategic Direction
Develops the strategy and drives the implementation of local tactics for Local Clinical Operations to meet both long-term and annual goals as cascaded from global function(s) or local affiliate
Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new therapeutic areas, as required by the development pipeline
Provides input and/or drives the prioritization exercise of the local Affiliate Medical Plan
Accountable for ensuring department budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensure adherence to budget forecasts
Contributes to global and local initiatives aimed at increasing quality and delivery of clinical operations activities (both globally and locally)
Local Study Management
Accountable for the execution of all data-generating activities (studies) conducted in the Affiliate, including all Roche sponsored and supported, interventional and non-interventional trials and that execution of these studies in compliant to ICH.GCP & GPP standards, Roche SOPs, local operating guidelines and local requirements including legal and financial standards and practices
Accountable for the establishment and effective operation of Local Study Management Teams including support and collaboration with all local affiliate departments to share information about nature of studies being conducted in the country
Accountable for setting up and maintaining an effective local FSP (Functional Service Provider) governance model to ensure overall study commitments, KPIs and provision of adequate resource in line with FTE demand projections (CRA / CTA) are met and that issues are escalated appropriately
Accountable for meeting country study commitments, in line with agreed country goals (budget, quality, patient recruitment and timeline) or in the event that study commitments are not going to be met ensures timely discussions are held with the study project team (global or local) and mitigating actions put in place
Develops a highly motivated team through effective leadership, coaching, and people management, ensuring an objective and performance-led management culture
Accountable for resource management, performance management and career development of Clinical Operations Staff
Actively participate in local HR activities to support and profile the Department at the local level (benchmarking etc. )
Represents Roche in respective Clinical Research committees, in professional associations
Develops and maintains excellent relationships and interactions between, the Clinical Operations team, Medical department, and other global, regional and local functions
Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with Roche policies and country legislation

State Clinical Operations Manager Resume Examples & Samples

Manage onsite Care Coordinators to ensure care for each consumer
Ensure intakes and referrals are documented in a timely manner
Refer consumer to appropriate social services provider based on intake information, consumer socioeconomic status, and consumer’s schedule Recognize local social service providers that connect with target population through community relations
Masters degree in healthcare, behavioral health, or related field
5+ years’ experience in healthcare management, staff selection and development, complex project management
5+ years’ experience in behavioral health, direct clinical practice
Basic level of proficiency with Microsoft applications such as (Word, Excel, Internet, Outlook)
Access to reliable transportation to travel to implementation sites within a designated area
Licensed Behavioral Health Professional in the State of Arizona

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