Clinical Research Manager
Fortrea · Bucharest
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.
- Fluent in English and Romanian.
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