Trial Master File Specialist

3 weeks ago

London, United Kingdom Seagen Full time

Position Summary:
The TMF Specialist is responsible for supporting a high quality TMF, performing quality checks, archival and retrieval of records for the Trial Master Files (TMF). Responsibilities include but are not limited to driving and overseeing successful completion of all TMF deliverables such as TMF System Business Administration tasks, TMF Plan development, TMF migrations, TMF set-up, QC review activities, and archiving.

Principal Responsibilities:
Clinical System Administration
- May act as Clinical System Business Administrator for user account management, study creation, and minor configuration updates
- Maintain study expected documents and milestones configuration and management
- Participate in validation activities related to major configuration updates and/or other clinical system integrations
- Remain current on clinical systems new releases and features of TMF platform in use, as well as staying current with technology trends related to TMF management

TMF Operations
- Ensure TMF file structure is dynamic and reflective of current regulations and company work practices
- Create and manage study TMF Plan in partnership with study team/CROs/Vendors, and perform vendor oversight activities
- Support TMF review process by working closely with study teams, CROs and Vendors
- Perform assigned TMF review actions in a timely manner
- Provide Clinical Study Teams with relevant reports and outputs to support maintenance of TMF Health
- Ensure periodic reviews are completed and determine additional quality reviews to promote continued quality improvement and user performance. Report trends to leadership.
- Support Clinical Study Teams in resolution of TMF-related queries or quality issues
- Support TMF audits and inspections as required

TMF Archiving
- Prepare TMF records (paper and electronic) for long-term, (off-site) archival in compliance with company procedures, GCP and other relevant global regulatory requirements
- Retrieve archived TMF records as required
- Perform quality checks and test retrievals of TMF records from long-term archival; document any findings and follow to resolution or escalation in compliance with company procedures, GCP and other relevant global regulatory requirements

Process Improvement and Training
- Communicate TMF process improvement suggestions to relevant stakeholders
- Support and/or deliver training across CRO, Vendors, or partners on the policies and procedures relative to TMF management
- Manage user requests/inquiries and maintain elements TMF guidance documents
- Foster positive relationships with external vendors and internal functional areas

Required Qualifications:

- Bachelor’s Degree or equivalent with related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment
- Excellent working knowledge of the TMF Reference Model
- Excellent knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
- Experience of electronic document management system(s) and eTMF; Veeva Clinical experience preferred but not mandatory
- Experience working in Gxp environment with validated systems
- Ability to work in a team environment as well as independently
- Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
- Ability to handle a high volume of complex tasks within a given timeline

Preferred Qualifications:

- Veeva Certification
- 5+ years of TMF experience, including experience in study start-up, maintenance and closeout activities. Subject matter expertise with the TMF Reference Model, clinical trial activities and related terminology
- #LI-LO1_

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