Clinical Research Associate Manager Remote

About This Role

Managing a team of Clinical Research Associates (CRAs) and ensuring strong monitoring in clinical trials is the core of this role. The manager will ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP. This position is critical for developing key talents by providing training, support, and mentoring to CRAs, and for managing situations of low or non-performance. The role will work at a country level with other local stakeholders to ensure alignment and development of country capabilities, and will collaborate with country Partner Line Managers (PLMs) for alignment across all monitoring functions. This person will contribute to HQ capacity/resource planning activities and will primarily work in Vaccine/Infectious Disease with some Cardiovascular therapeutic areas.

Responsibilities

• Manage a team of 6-14 Clinical Research Associates (CRAs)
• Ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP
• Continuously develop key talents by providing training, support, and mentoring to CRAs
• Properly manage situations of low or non-performance
• Work at country level with other local stakeholders (e.g., Clinical Research Managers) to ensure alignment and development of country capabilities
• Collaborate with country Partner Line Managers (PLMs) to ensure alignment across all monitoring functions
• Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work
• Work allocation, staff development, and performance appraisal
• Support departmental company initiatives and work streams
• Provide input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources
• Work with CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability
• Interact with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM
• Attend local Investigator Meetings if requested
• Interface with GCTO partners on clinical trial execution
• Escalate site performance issues to Head of Site Management and Monitoring
• Manage CRA career development and performance reviews, including addressing low performance situations and taking appropriate actions
• Support and resolve escalation of issues from CRAs
• Liaise with local HR and finance functions as required
• Manage local conflicts between resource and work
• Ensure CRA compliance to corporate policies, procedures, and quality standards