Associate Clinical Research Manager

Fortrea


Job Location:

Bucharest - Romania

Monthly Salary: Not Disclosed
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.

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    Required Experience:

    Manager

    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 perfor...

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