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Manager, Global Clinical Monitoring – CRA Line Manager
Precision Medicine GroupManager leading and developing CRAs at Precision Medicine Group, ensuring high-quality clinical monitoring services. Overseeing CRA performance and resource allocation for clinical trial operations.
About the role
Key responsibilities & impact- Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals
- Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams
- Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately
- Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability
- Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues
- Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees
- Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
- Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems
- Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution
- Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics
- Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process
- Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas
- Represent Precision for Medicine in a professional manner
- Manage CRA staff in accordance with Precision for Medicine’s values and policies
- Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans
Requirements
What you’ll need- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
- Extensive experience in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry, with a minimum of 5 years onsite monitoring experience
- 3-5 years of direct supervisory experience managing CRAs
- Experience creating effective development programs for clinical staff
- Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards
- Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical operationsdata managementmonitoringdevelopment programsevaluation processesgap analysistrainingmetrics developmentresource allocationproject management
Soft Skills
leadershipmentoringcoachingcommunicationcollaborationproblem-solvingaccountabilitystrategic oversightquality assuranceperformance feedback