Clinical Trial Manager

New

Skills

Clinical Research Clinical Trial Management CTMS eTMF ICH-GCP Interpersonal Skills Monitoring MS Office Organizational Skills Regulatory Submissions

The Clinical Trial Manager/Senior Clinical Trial Manager will lead the planning, conduct, and oversight of operational portions of clinical studies in alignment with project scope. This role serves as the primary clinical point of contact with clients and is critical in ensuring the successful execution of clinical trials.

Key Responsibilities
  • Develop study documents including clinical plans, ICF templates, CRF guidelines, manuals, and trackers.
  • Identify training needs for Clinical Research Associates (CRAs) and vendors; present at Investigator Meetings.
  • Generate site lists and manage the site feasibility process.
  • Oversee submissions and approvals to authorities and IRB/Ethics Committees in collaboration with regulatory teams.
Requirements & Qualifications
  • Bachelor's degree or equivalent; advanced degree preferred.
  • 7+ years of clinical research experience with significant monitoring.
  • Excellent communication, interpersonal, and organizational skills.
  • Proficiency with MS Office; experience with CTMS/eTMF is a plus.
  • Strong knowledge of ICH-GCP, SOPs, and regulatory guidelines.
  • Ability to travel domestically and internationally, including overnight stays.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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