The Clinical Research Manager (CRM) leads the execution and oversight of clinical trial activities within an assigned country, ensuring compliance with ICH-GCP, local regulations, and company quality standards. Acting as the primary country-level contact for assigned studies, the CRM drives study performance, operational delivery, regulatory compliance, and stakeholder engagement while partnering with internal teams, investigators, and external vendors.
Key Responsibilities
Lead country-level delivery of assigned clinical trials, ensuring timelines, quality standards, and regulatory requirements are met.
Serve as the primary point of contact for assigned studies and oversee study execution, budgets, contracts, and resource planning.
Provide quality oversight of CRAs, CTCs, vendors, and study activities, including monitoring compliance and training requirements.
Support site identification, feasibility, selection, activation, recruitment, and investigator engagement.
Build and maintain strong relationships with investigators, sites, vendors, and key external stakeholders.
Collaborate cross-functionally with Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Regional Operations to support study delivery and country strategy.
Mentor junior team members and contribute to continuous improvement initiatives.
Qualifications & Experience
Degree in Life Sciences, Nursing, Pharmacy, Medical Technology, or a related field; equivalent clinical research experience will also be considered.
6–8 years of clinical research experience within a pharmaceutical company or a CRO
Experience as a Lead CRA or coordinating CRAs
Strong knowledge of ICH-GCP, clinical trial regulations, drug development processes, and local regulatory requirements.
Experience managing clinical studies and coordinating cross-functional stakeholders.
Excellent communication, organisational, and stakeholder management skills.
Proven ability to work independently, manage multiple priorities, and lead in a matrix environment.
