TMF Study Owner

We are growing, grow with us!
Are you a Trial Master File expert looking for your next role? Then, Pharmalex is your career opportunity!
Pharmalex is one of the leading service companies for the Pharmaceutical industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. Customers place their trust in Pharmalex because of our proven mastery over the TMF-related questions and challenges they face every day.

Our Professional Services team are a growing team of 50+ diverse individuals with unique expertise and experience, offering Study Resources, Study Services and Consulting Services to customers. The services are designed to work independently as well as collaboratively, fitting the customer's needs and budget.

TMF Study Owner

The TMF Study Owner provides pivotal support and subject matter expertise (SME) at a study level, proactively ensuring our clients' Trial Master Files (TMFs) are achieving an inspection ready state. They are an integral part of the study team, becoming a single point of contact to help maintain TMF health, consistency, and compliance across clinical trials within the organisation.

This is a fully remote role with working hours expected to match the requirements of the customer's business day. Travel is not an expectation of the role, however occasional travel may be required depending on customer requirements, for example in the case of an inspection or to complete paper TMF activities.
Candidates must be based in the UK for this opportunity.

Your Job

Document Management & Quality

• Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices.

TMF Management

• Support the setup of the study-specific TMF structure, liaising with the Study Team to establish requirements.
• Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented.
• Monitor milestones and events to ensure TMF Completeness via eTMF functionality.
• Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team.
• Support study team through closeout and archive preparations.
• Ensure ongoing adherence to TMF SOPs and specifications.
• Create study-specific TMF Index (or equivalent).

TMF Health & Metrics

• Perform and/or support Quality Review and perform spot-checks for quality oversight.
• Provide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintaining.
• Help facilitate, track, and support periodic Study Team TMF Reviews.
• Perform a deep-dive of report outputs; identify and share trends and risk areas with Study Teams.

Inspection Readiness

• Manage remediation and reconciliation projects.
• Manage inspection preparation.
• Support audits and inspections.
• Support implementation of CAPAs at study level.
• Identify and escalate risk and trends impacting Inspection Readiness.

Customer Relationships

• Facilitate TMF-focused communication and collaboration between Sponsor and CROs.
• Communicate to the Study Manager (or equivalent) on all aspects of the TMF.
• Build proactive relationships with study teams, providing continued SME support.
• Understand and utilise appropriate escalation pathways.

Policies & Procedures

• Provide feedback on processes relating to TMF Management.

Training & Mentoring

• Act as TMF SME, including related processes, to provide ongoing support to Study Team.
• Provide feedback to support development of internal and/or external TMF-related trainings.
• Conduct training for Study Team and/or colleagues, either 121 or in group setting.

Your Profile
 

• 5 years relevant industry experience in Clinical or TMF Operations oversight is essential.
• Excellent knowledge of:
  • Good Documentation Practices (GDP)
  • Document recognition
• Good knowledge of:
  • Referencing/Applying applicable resources
• Working knowledge of:
  • Clinical trial lifecycle
  • TMF Reference Model (or equivalent)
  • eTMF systems
  • TMF Health & Metrics, including Quality Review process
  • Internal communication/escalation pathways
• Familiar with:
  • TMF lifecycle
  • Other clinical/document management systems
  • TMF stakeholders
  • End to end tasks, including TMF set-up process and Management Plans
  • TMF training
  • Inspection Readiness
  • External communication/escalation pathways

• The salary will be commensurate with the candidate's experience
• 25 days holiday plus BH (increasing to 27 after qualifying service)
• 8% employer pension contribution (pro rata)
• An opportunity to work within an organisation with a positive work/life balance environment 
• Continuous development opportunities through knowledge and experience as well as training

If you are interested in joining our Cencora PharmaLex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don't hesitate to contact us.

 

Agencies only by prior agreement for the specific job opportunity.