TMF Administrator
- Employer
- Warman O’Brien
- Location
- London (Central), London (Greater) (GB), Remote, Homeworking
- Salary
- Excellent Daily Rates
- Start date
- 3 May 2022
- Closing date
- 2 Jun 2022
View more
- Discipline
- Clinical Research, Clinical Administrator
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
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
Company
Warman O’Brien is a global specialist Life Sciences Recruitment Partner across the UK, Europe, USA and APAC. We recruit top talent across a number of functional areas including:
- Biometrics
- Data Sciences
- Quality Assurance
- Regulatory Affairs
- Clinical Research
- Discovery Sciences
- C-Suite
- Medical Affairs
We cover contract and permanent vacancies, executive search, and SOW for companies across the pharmaceutical industry.
Find out more on our website warmanobrien.com/
- Website
- https://warmanobrien.com/
- Telephone
- +44 (0) 2033255075
- Location
-
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
United Kingdom
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