Associate Clinical Research Manager
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
- 68 years of clinical research experience within a pharmaceutical company or a CRO
- 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.
Learn more about our EEO & Accommodations request here.
Required Experience:
Manager