Premier Research is looking for a TMF Lead II to join our Pharmacovigilance and Records Management team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
POSITION SUMMARY:
Performs electronic and/or paper Trial Master File records management activities ensuring that TMF records are managed according to Company, Sponsor, Industry, ICH-GCP and global Regulatory standards. Leads the set-up, maintenance and closure of TMFs, including development and ownership of study TMF Plans and indexes. May perform TMF Transitions and use Sponsor TMF processes and systems. Provides oversight, training, KPI analysis and reporting of TMF status to ensure Premier project teams, Sponsors and Third Parties are compliant with prevailing TMF SOPs, TMF Plans and TMF Transition Plans. Takes initiative to identify and address TMF quality and completeness deficiencies that may impact audit and inspection readiness as well as the successful delivery of high-quality TMFs.
ROLE RESPONSIBILITIES:
- Acts as primary TMF point of contact for project teams, Sponsors, auditors and other third parties for assigned studies.
- Works directly with the records specialists assigned to their studies.
- Works with eTMF Administrator to identify and assist in the resolution of system related issues if/as needed.
- Reads and understands the TMF scope of work to be performed on assigned studies. Identifies any out-of-scope activities and reports to department management for change order consideration on assigned studies.
- Provides regular TMF status updates to Project Leadership and Functions on the quality and timeliness of document submissions on assigned studies.
- Assists with monitoring the security, environment and access control of Secure File Room (SFR) facilities (if applicable).
- Monitors compliance to TMF SOPs and TMF Plans for assigned studies.
- Performs live, web-based and/or recorded TMF process and systems training for Premier project teams, Sponsor and other Third Parties on assigned studies.
- Performs all departmental budgeted activities for assigned studies.
- Develops, signs and maintains TMF Plans, TMF Transition Plans and indexes for assigned studies.
- Participates in TMF audits and inspections as TMF representative for assigned studies.
- Coordinates project team quality reviews of TMFs in accordance with TMF SOPs and TMF Plans for assigned studies.
REQUIREMENTS:
- Minimum of a high school diploma or international equivalent required. Undergraduate degree preferred from an accredited institution majoring in records and information management, library science, clinical, science or health related field preferred - or – an equivalent level of clinical trials records management experience.
- 8+ years eTMF systems experience required.
- 8+ years of Trial Master File management experience required.
- 8+ years TMF Reference Model experience required.
- 2+ years TMF Lead experience required.
- Knowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and Global Regulations related to the investigational drug and device industry required.
