Clinical Project Manager

Found in: beBee S TW - 3 weeks ago


Taipei, Taiwan Fyte Full time
Position Overview:
We are seeking a highly motivated and experienced Clinical Project Manager to join our team. The Clinical Project Manager will be responsible for the overall management and execution of clinical trials, ensuring compliance with regulatory requirements, timelines, and budget constraints.

Key Responsibilities:
  • Manage all aspects of clinical trials, including study planning, start-up, execution, and close-out phases.
  • Develop and manage study timelines, budgets, and resource allocation to ensure successful trial completion.
  • Coordinate and lead cross-functional project teams, including Clinical Research Associates (CRAs), Data Managers, and other key stakeholders.
  • Oversee site selection, initiation, and monitoring activities to ensure adherence to protocol and regulatory requirements.
  • Serve as the primary point of contact for sponsors, investigators, and study sites, ensuring effective communication and resolution of issues.
  • Track study progress, identify potential risks or challenges, and implement mitigation strategies as needed.
  • Ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs.
  • Prepare and review study-related documents, including protocols, informed consent forms, and clinical study reports.
  • Participate in bid defense meetings, proposal development, and client presentations as needed.
Qualifications:
  • Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
  • Minimum of 5 years of experience in clinical trial management within the CRO or pharmaceutical industry, with at least 3 years of experience specifically as a Clinical Project Manager.
  • Strong understanding of clinical trial regulations, including ICH-GCP guidelines and FDA/EMA requirements.
  • Ability to work effectively in a fast-paced environment and adapt to changing priorities.
  • Proficiency in Microsoft Office applications and clinical trial management systems (CTMS).

 
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