Previous Job
TMF Associate
Ref No.: 18-02039
Location: South San Francisco, California
Position Type:Contract
The TMF associate will work under direction of the TMF Specialist in the Trial Master File (TMF) related activities and maintenance of Trial Master File (TMF). Duties will include but not limited to document quality control, reconciliation and close-out and archiving activity in accordance with Good Clinical Practice (GCP), ICH Guidelines and other regulatory guidance documents, relevant regulation (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trial Directives), and company Standard Operating Procedures (SOPs) and Drug Information Association Reference Model 3.0, as appropriate.

  • Facilitate quality check, filing, archival, and tracking of Trial Master File (TMF) documents in the Clinical TMF Mailbox in compliance with work process documents, company Standard Operating Procedures (SOPs) and Good Documentation Practice (GCP) regulations for clinical conduct
  • Work with project team members to mitigate TMF document issue findings, follow through until findings are resolved and confirm correct documents are filed using the regulatory document tracker or associated reports
  • Escalate TMF document findings that may be vague to TMF Specialist to identify course of action
  • Proactively seek clarification and direction regarding any project, activity, timeline as assigned from TMF Specialist
  • Populate regulatory document trackers and associated documents to record TMF document quality, reconciliation and close-out details
  • Reconcile electronic against paper TMF documents for legacy and closed studies
  • Support TMF related projects and activities as assigned

  • At least 4 years relevant clinical research experience including 3 years of clinical TMF Administration in Pharmaceutical or Biotechnology company. Post high school education (e.g., Associates or Bachelor's Degree) considered a plus.
  • Strong, open and transparent communication skills (verbal and written)
  • Consistent and timely attendance is required
  • Experienced in handling trial essential documents required
  • Capable of working on multiple projects/tasks and able to meet timelines
  • Strong knowledge of the DIA Reference Model
  • Knowledge of FDA Regulations, ICH Guidelines, GCPs and standard clinical operating procedures
  • Proficiency with Microsoft Office Suite, electronic data management systems required