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Clinical TMF Studies Specialist

Biotech-Pharmaceutical Industry
Bedminster, NJ Full Time
POSTED ON 2/28/2025
AVAILABLE BEFORE 5/25/2025

Contract Clinical TMF Studies specialist - (Hybrid, W2 only, No third parties or C2C)

  • This role is with a global pharmaceutical company located in NJ.

Key Responsibilities :

  • Coordinate meetings, including scheduling, agenda preparation, and minute-taking.
  • Gather data for feasibility assessments and site selection, and maintain site usability records.
  • Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs.
  • Assemble and update study manuals and maintain version control of study materials.
  • Monitor site activation, enrollment, and study progress, and escalate any issues or deviations.
  • Maintain investigator and site status updates, and support clinical trial registry postings.
  • Perform regular reconciliations of the Trial Master File (TMF).
  • Ensure timely receipt of required reports.
  • Manage team SharePoint or shared drive sites and maintain site contact information.
  • Assist in managing third-party vendors and tracking study close-out activities.
  • Participate in SOP revisions and propose process improvements.

    • Qualifications :

  • Strong attention to detail and ability to manage study activities effectively.
  • Good communication and interpersonal skills.
  • Problem-solving abilities and proactive approach to tasks.
  • Familiarity with trial management systems and MS Office applications.
  • Basic understanding of clinical drug development and ICH / GCP guidelines.

    • Experience :

  • Bachelor’s degree with 3 of relevant experience

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