TMF Administrator

An experienced TMF Administrator is required to join a global biotech on an initial 6 month contract. This contract will operate inside of IR35.

Based in central London, my client is looking for a TMF specialist to join a small global team, and to be responsible for management and quality maintenance of essential trial documents across a portfolio of studies. The individual will ensure the TMF is audit and inspection ready for all clinical trials.

What you will be doing:

• Management of TMF, that includes setup, collection, coordination and maintenance and archiving of TMF
• Assist in designing, updating and implementing the processes for clinical trial document management and trial records
• Partner with members of the clinical team and CROs to ensure submission readiness and inspection readiness of TMF
• Train individuals on the TMF system and processing rules
• Single point of contact for all TMF related manners
• Evaluate clinical study requirements and ensure the appropriate TMF is developed prior to study start
• Manage quality metrics around TMF completeness and generate regular reports for use by study teams and management
• Ensure identified discrepancies are addressed and resolved in a timely manner

What you can bring to the role:

• 2+ years of experience in the pharmaceutical industry
• Bachelor’s degree in life sciences, preferable
• 1.5+ years experience with TMF
• Experience with Drug Information Association (DIA) trial master file reference model, along with a though understanding and appreciation of records management best practices
• Well versed in clinical site operations
• Prior experience supporting internal audits and health authority inspections
• Through understanding of GCP

What you get in return:

• Flexible working environment (1-2 days office based in Central London)
• Competitive daily rates
• Collaboration with a great team
• The potential for a longer-term contract