Clinical Research Associate (CRA) Manager

About the role

This role is pivotal for strong monitoring of clinical trials. Reporting to the Clinical Research Director, the manager leads a team of 6‑14 Clinical Research Associates (CRAs) to ensure excellent study and site performance while adhering to local regulations, company SOPs and ICH GCP.

Key responsibilities

• Allocate work, develop staff, and conduct performance appraisals for the CRA team.
• Provide capacity planning input, reporting current manpower and forecasting future CRA needs.
• Coordinate with CRAs, PLMS and other functions to ensure consistent protocol implementation across the country.
• Resolve site or CRA operational issues in collaboration with study CRM to meet timelines.
• Attend local Investigator Meetings and interface with GCTO partners on trial execution.
• Escalate site performance concerns to the Clinical Research Director and manage low‑performance situations.
• Support and resolve escalations from CRAs.
• Liaise with local HR and finance functions as required.

Required profile

• Proven experience managing a team of CRAs in a clinical research environment.
• Strong knowledge of local regulatory requirements, ICH GCP and company SOPs.
• Ability to develop talent, provide training, mentorship and address performance issues.
• Effective collaboration with country‑level stakeholders and partner line managers.

Required skills

• Clinical Research
• Clinical Research Management
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Clinical Trials Operations
• Oncology Trials
• Good Clinical Practice (GCP)
• Regulatory Compliance