Clinical Operations Manager Job Description

Clinical Operations Manager Job Description

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Clinical operations manager provides timely and accurate guidance to affiliate staff on the effective implementation of ICH GCP, existing or revised global and local Controlled Documents, regulatory and local law requirements.

Clinical Operations Manager Duties & Responsibilities

To write an effective clinical operations manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical operations manager job description templates that you can modify and use.

Sample responsibilities for this position include:

Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process
Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function
Act as a coach and mentor for lower level staff as they develop in their role
Understand global regulatory requirements for clinical trial disclosure
Serve as work instruction and associated forms owner for clinical trial disclosure requirements globally
Assist study teams in determining clinical trial disclosure requirements for each clinical trial
Complete protocol registrations in all required governmental databases
Maintain and update registrations in all required governmental databases
Post results as required to all required governmental databases
Facilitate quarterly clinical trial disclosure meetings with Clinical Operations

Clinical Operations Manager Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Operations Manager

List any licenses or certifications required by the position: CPR, PMP, BLS, ACRP, ACLS, AHM, CAPA, CPAN, AHA, APICS

Education for Clinical Operations Manager

Typically a job would require a certain level of education.

Employers hiring for the clinical operations manager 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 Clinical Operations Manager

Desired skills for clinical operations manager include:

Local regulatory environment and submission and approval processes
ICH GCP
EU CTD
Global regulatory and compliance requirements for clinical research
Microsoft Office applications
Budget and contract negotiations
ICH-GCP guidelines and ability to review and evaluate medical data
Understanding of how these impact study start-up
Drug development process
ICH

Desired experience for clinical operations manager includes:

Able to make timely decisions, support those decisions with appropriate information
Ability to learn and function in multiple mainframe systems
Bachelors Degree, or local equivalent, in life sciences, medicine or related discipline
Assists with determining goals, objectives, outcome measurements and metrics, recharge feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations
Master’s or other graduate level degree or the equivalent of education, training and experience from which comparable skills can be acquired
Knowledge of applicable federal and state laws and regulations related to the health care industry

Clinical Operations Manager Examples

1

Clinical Operations Manager Job Description

Job Description Example
Our company is looking to fill the role of clinical operations manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical operations manager
  • Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
  • Solve or coordinate the resolution of issues during conduct of the trial
  • Develop and review specific study-related documents
  • Develop and coordinate the study budget, including invoice validation
  • Contribute to contract process
  • Manage investigational product supplies (ordering, packaging, and shipment)
  • Participate in and contribute to internal audits, if applicable
  • Serve as main contact for clinical sites and other outsourced activities
  • Manage local MT (CSUs) when applicable
  • Manage outsourced centralized activities when applicable (Central Lab)
Qualifications for clinical operations manager
  • Bachelor’s Degree + 5 years pharmaceutical and/or device clinical development experience including clinical trial disclosure activities
  • Bachelor's degree plus at least 10 years of experience in pharmaceutical industry or clinical-related discipline including at least 8 years clinical research experience
  • Experience in managing and leading international meetings
  • Ability to lead transversal projects
  • Capability to challenge decisions/status-quo/requests using risk management approach
  • Cross-functional leadership fostering team spirit and team motivation (team work), study team or transversal project team
2

Clinical Operations Manager Job Description

Job Description Example
Our innovative and growing company is hiring for a clinical operations manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical operations manager
  • Identify regional CLO risks and mitigations and share with the Study Lead
  • Identify, resolve or, if necessary, escalate regional CLO issues that have a significant impact to overall global CLO study timelines, other functions, budget or quality to the Study Lead as per study team / project team charter
  • Lead CLO regional study activity timeline development and contribute to regional study budget development and management
  • Provide regional/local operational and regulation knowledge to Study Lead as related to the study(ies) in support of enrollment strategies
  • Provide regional study status updates to Study Lead
  • Lead site identification, qualification, selection and activation activities for the study, such as site and staff training, site budgets, site or country specific ICF and site investigator contracts
  • Plan and deliver IM in collaboration with other key stakeholders
  • Under supervision of Sr
  • Communicates with study investigators in all phases of the study
  • Negotiates site-specific study budgets, initiates and oversees contract origination, compliance approval, and execution
Qualifications for clinical operations manager
  • Experience in Quality Assurance activities associated with Good Clinical Practices (GCP) in support of clinical studies
  • Bachelor's Degree and 8+ yrs
  • 5+ years in clinical research
  • Field monitoring experience or related experience is required (approximately 3-5 years)
  • Clinical Trials Management or Project management experience (approximately 3-5 years) and recognized in cross functional operations
  • General understanding of R&D processes including the principals of study design and execution
3

Clinical Operations Manager Job Description

Job Description Example
Our growing company is looking for a clinical operations manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical operations manager
  • Ensure projects supported by clinical operations team have been prioritized, budgeted and resourced by Product Managers
  • Support associate development to maintain the highest level of engagement
  • Lead and manage development efforts and relationships with new or existing investigators and other area healthcare entities
  • The Clinical Program Manager within the Mother Baby Clinical Service Line will have primary accountability for providing quality/data support and project management for the inpatient and outpatient areas of MPP/OB/Gyn and normal newborn nursery
  • Position includes best practice program design and a focus on continuous improvement across sites
  • Encourage collaboration and optimization of system resources across North/East/West regions and participate on sub-groups of clinical experts to continually improve services to patients & families
  • Provide information on dashboards and monitoring systems to highlight ROI / value of support programs to the overall Service Line and patient outcomes
  • Drive programmatic outcomes that are measureable, repeatable and financially sustainable
  • Evaluate system vs
  • Communicate and negotiate with system on hardware, software and network needs/ requirements
Qualifications for clinical operations manager
  • Knowledge of data management activities
  • At minimum, a bachelor’s degree in nursing, science or health related field required
  • Experience of early phase and registrational trials preferred
  • At least 1 -2 year of experience in line management or local project management and/or start up
  • Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO
  • Previous experience as a Clinical Trial Manager, Clinical Study Manager, or Clinical Research Manager
4

Clinical Operations Manager Job Description

Job Description Example
Our company is growing rapidly and is hiring for a clinical operations manager. 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 clinical operations manager
  • Ensures compliance of the clinical practice with all pertinent regulations
  • Trains, coaches and evaluates the performance of clinic employees
  • Develops and administers the clinic budget and ensures cost effective operations
  • Develops policies and procedures and updates clinic operations
  • Ensures patient satisfaction and handles operational problems as they arise
  • Implement the oversight and monitoring strategy and associated systems
  • Develop and implement QMS for monitoring activities and create metrics, key quality and performance indicators
  • Report out metrics to Sr
  • Ensure audit and inspection readiness of assigned sites
  • If assigned
Qualifications for clinical operations manager
  • Certified Research Professional
  • Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
  • Project management skills, effective communication (written and verbal), adaptability and self-motivation
  • Phase 2-4 multispecialty experience preferred
  • Deep knowledge and experience with the use of TMF systems and associated business processes
  • Excellent working knowledge of International Conference on
5

Clinical Operations Manager Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical operations manager. 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 clinical operations manager
  • Accountable for functional budget planning and administration
  • Drives a learning environment and ensures continuous improvement in Country/District(s) performance by using innovative approaches, active analysis of Key Performance Indicators, metrics and milestones
  • Partner with clinical team to ensure quality
  • Advises and supports Plans and internal business partners on data analysis and reporting in support of benefit cost and/or care management initiatives
  • Assist Director with the orientation and training of all newly hired physicians and staff of CCP
  • Communicate regularly with Coordinators Ancillary/Clinical Support Service on progress toward defined goals and/or required results
  • Develop or assist with the development and implementation of policies and procedures consistent with those of CCP
  • Follow an internal site audit, work with professional and management staff to ensure understanding of clinical support and safety requirements and develop a corrective action plan
  • Monitor and ensure that all office sites are in compliance with all policies, procedures, and guidelines
  • Oversee the supervision of Coordinators, Ancillary/Clinical Support, which includes work allocation, training, and problem resolution
Qualifications for clinical operations manager
  • Active partnership building for assigned studies and collaboration with therapy aligned staff in other functions
  • Bachelor’s degree from an accredited institution in Health Sciences, Heath Care, Nursing or Others
  • Minimum of five (5) to six (6) years of relevant business experience in the regulated pharmaceutical or healthcare industry
  • Clinical development or compliance experience preferred
  • Knowledge of the different functions involved in the planning, conduct and monitoring of clinical trials
  • Working knowledge of clinical research principals and process

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