Manager, Clinical Operations Job Description
Manager, clinical operations
provides reviews of protocols, amendments, and other study specific documents as requested for compliance with internal standards, international regulations and ICH GCP guidelines.
Manager, Clinical Operations Duties & Responsibilities
To write an effective manager, clinical operations job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, clinical operations job description templates that you can modify and use.
Sample responsibilities for this position include:
May provide key country input to Shire study team in the generic assessment of clinical research documents and tools, monitoring plan, meeting materials/manuals
Responsible for generic review of translated consent and other patient related documents and/or translations for study materials in country-specific language
Responsible for building in-country relationships with our clinical trial investigators & site staff
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
Collects, analyzes, synthesizes and/or maintains complex data utilizing databases, survey instruments, information resources, or other research methodology
For direct reports, ensures clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives
Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives
Participates in field training and mentoring of new/junior SCRAs insourced SCRAs
Creates and maintains a highly motivated team by providing a high level of leadership, people management, coaching and development
Works collaboratively with global and local stakeholders to assist the local study team in the management and escalation of issues and challenges
Manager, Clinical Operations Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Manager, Clinical Operations
List any licenses or certifications required by the position: CPR, PMP, BLS, ACRP, ACLS, AHM, CAPA, CPAN, AHA, APICS
Education for Manager, Clinical Operations
Typically a job would require a certain level of education.
Employers hiring for the manager, clinical operations job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Education, Nursing, Life Sciences, Leadership, Business, Health Care, Biotechnology, Science, Medical, Healthcare
Skills for Manager, Clinical Operations
Desired skills for manager, clinical operations include:
Basic financial concepts as related to forecasting and budgeting
GCP/ICH guidelines and other applicable regulatory requirement
Specific Area of Expertise within a phase
FDA
Microsoft Office applications
EMA Regulations
GCP governing the conduct of clinical studies
ICH Guidelines
New therapeutic areas
GCP
Desired experience for manager, clinical operations includes:
Line management responsibilities including professional development, performance appraisals, and employee counseling for staff
Manage the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions
Ensures quality and adherence to SOP/WI
Proficient in medical terminology, sufficient to understand medical records
Able to analyze and present data illustrating compliance, performance, issues, strategies
Excellent interpersonal skills that allow successful interaction with physicians, nurses, non-clinical staff, and members
Manager, Clinical Operations Examples
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Manager, Clinical Operations Job Description
Job Description Example
Our growing company is looking to fill the role of manager, clinical operations. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for manager, clinical operations
- Process developer for Clinical Operations interface with global clinical trial disclosure requirements
- Provide subject matter expertise and training materials and presentations for clinical study teams
- For device studies, act as primary point for receipt of SAEs and product complaints/deficiencies data, reviewing for completeness or need for clarification in collaboration with the Medical Monitor, GPS and/or GFS
- Manage on-site day-to-day clinical laboratory operations, oversee facility maintenance, and ensure that the facility operates within established budgets
- Coordinate with MDs, Laboratory Technicians, and Research Associates to oversee implementation of research protocols and recruitment
- Ensure staff are compliant with all relevant regulatory requirements (i.e., Good Clinical Practice Guidelines)
- Ensure that staff have the proper materials, systems access and training to complete job responsibilities
- Provide management and oversight of clinical trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines
- Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units)
- Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations, with responsibilities on product and project level
Qualifications for manager, clinical operations
- Bachelor degree in Nursing, Business, Accounting, or in a related field
- Five years of directly relevant work experience in a related medical setting with Bachelor degree
- Bachelor Degree preferably in Business or Life Sciences or equivalent experience
- Frequent travel, approximately 30-40% of work week
- Has working knowledge and familiarity with ClinicalTrials.gov, EudraCT and EudaMed
- An enthusiasm to further develop regulatory knowledge of clinical trial disclosure requirements globally
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Manager, Clinical Operations Job Description
Job Description Example
Our company is looking for a manager, clinical operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, clinical operations
- Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate
- Report visit progress/findings to CSD and other relevant members of the CTT and Site manager
- Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees
- Utilize department mentoring program
- Track mentoring/training progress by meeting with mentee on regular basis
- Participate in intra or inter-department Working Groups, if applicable
- Participate in development/improvement of guidance documents
- Participate with Study Lead on regional study feasibility assessment activities (if applicable)
- Ensure timely development and finalization of region specific sections of study plans and manuals as per the study team / project team charter
- Contribute to the development and review of region specific elements of critical study documents, such as study protocol, eCRF, ICF template, and others
Qualifications for manager, clinical operations
- Provides leadership and work as a member of a professional team
- Travels within the Service Area, region and state
- Works in a Labor/Management Partnership environment
- Minimum of 5 years applicable work experience in a clinical research environment
- Must be detail oriented, good communicator, used to working in a team environment, yet able to work independently
- Good oral and written communication skills and must possess effective English language and grammar skills
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Manager, Clinical Operations Job Description
Job Description Example
Our growing company is looking for a manager, clinical operations. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manager, clinical operations
- Liaison among clinical site staff, biopharmaceutical company personnel and internal stakeholders (R&D, Regulatory Affairs, Quality Assurance, ) to ensure xxx
- Consults with customers (physicians, health plan/regulatory stake holders, state partners, ) regarding status of prior authorization and/or issues related to such
- Managing the start-up team, drive for result and keeping timelines
- Responsibility for appropriate management and resolution of performance issues
- Measuring performance indicators for assigned staff
- Identifying individual training needs and assist in the conduct of training and development efforts, regionally
- University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- Preferably Masters or other advanced degree
- Overall knowledge of EC/RA submission, IP packs contracts and budgets
- Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff
Qualifications for manager, clinical operations
- Experience with management of outsourced activities
- The qualified candidate must have BA/BS or equivalent
- Tact and diplomacy is a strength
- Knowledge of computer software and meticulous attention to detail expected for this position
- Demonstrated ability to represent Clinical Operations in global project teams, execute clinical strategies and manage complex programs in a fast paced milestone focused environment
- Has a track record of delivering on commitments
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Manager, Clinical Operations Job Description
Job Description Example
Our innovative and growing company is hiring for a manager, clinical operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, clinical operations
- If applicable, provide oversight of contracted personnel for performing CO Quality activities
- Develop and maintain working relationships with Quality Medicine, cross-functional partners in Legal, and other Med/RA functions to assure a closely coordinated program of CO Quality activities based on common goals and objectives
- Support execution of process improvement initiatives, including training programs to address quality and/or performance issues
- Support and/or lead in-house inspection readiness activities and participate in sponsor and research site regulatory inspections, as requested
- Represent department on local/global working groups, as requested
- Partners with key business stakeholders to ensure a successful project completion
- Experience developing and implementing clinical work flows and processes
- Manages the daily operations of a medical clinic
- Supervises the business operations related to patient registration and services, billing and collections, and budgeting, marketing, and supplying
- Develops or participates in the development of clinic objectives and long- range and strategic plans
Qualifications for manager, clinical operations
- Bachelor's degree plus at least 7 years of experience in pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience, including 2 years of trial operations management
- Ability to work in an international environment with internal and/or external partners (CROs etc)
- 10-30% travel by plane and car as required with overnight and domestic/potential international travel
- Ability to drive and have a valid driver’s license as appropriate per country travel norms
- Degree in Science, with a major in Pharmacy or Nursing from a recognized tertiary institution
- At least 3 years of experience working on clinical trials, preferred with 1 year experience in a leadership capacity
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Manager, Clinical Operations Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of manager, clinical operations. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manager, clinical operations
- Independently oversees the functionality of study related documents such as Source Document Worksheets, Informed Consent Checklists, Concomitant Medication page
- Supervise assigned clinical staff
- Responsibility for the supervision of assigned direct reports
- Measuring performance indicators for assigned staff within Clinical Operations
- Conducting on-site Accompanied Field Visit activities (Evaluation and Quality Control Visits) for Clinical Operations staff
- Proficiency with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
- Interacts with internal and external groups (CRO’s, vendors, clinical sites, ) to facilitate clinical trials and achieve designated timelines
- Oversees study timelines, clinical trial budgets, coordinates development of study plans
- Keeps management informed of escalating issues requiring intervention into a study or project team
- Ensures audit and inspectionreadiness at all times
Qualifications for manager, clinical operations
- Team players who are able to work independently
- Harmonization/ Good Clinical Practice regulations and Corporate & R&D policies and Standard Operating Procedures for sponsor study records
- BS in scientific discipline
- Make decisions which balance risk/benefit with clear understanding of impact on the study
- Provides support to the Study Accountable Person (SAP) as appropriate to ensure the accurate and complete compilation, maintenance and archiving of study records trial master file (TMF)
- Develops and implements study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders