Trial Master File Lead - UK home based
Trial Masterfile Lead
Office based - Farnborough
We are currently looking to strengthen our Document Control team in Europe and are seeking a Trial Master File Lead (TMF Lead) to join our team. Ideally the person will be based in our EU HQ Farnborough office, however other locations may be considered.
A brief summary of duties:
• Attends Trusted Process meetings such as Kick-Off, Quick Start Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
• Leads the TMF set-up and structure, configures completeness reports and sponsor/project specific completeness reports, and develops the list of expected documents and the gap analysis.
• Collaborates with the Project Lead (PL) and Functional Leads (FL)
• Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project/program.
• Designs and/or delivers study specific TMF training
• Generates and provides Completeness Reports and inspection readiness metrics to the Project Team.
• Participates in audits/inspections and prepares for audits to ensure audit-readiness for the TMF.
To succeed in this role you will need the following skills/experience:
• BA/BS in the life sciences, business administration, or related discipline; or equivalent combination of education and experience.
• Moderate experience in a Contract Research Organization or related field.
• Experience with leading/co-leading studies from award into maintenance on a Global scale.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
• Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
• Ability to perform several tasks simultaneously to meet deadlines
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.