Trial Master File Lead - UK Home or Office Based
- Experience Level
- Experienced (non-manager)
Trial Master File Lead
UK home based or office-based
Here at Syneos Health we are currently recruiting for a Trial Master File Lead to join our global TMF Operations team.
As a Trial Master File (TMF) Lead you will provide oversight of all TMF management activities for your projects, from initial award through to final transfer. Strong leadership of TMF activities throughout a project is an integral part of its overall success, and your role as a Subject Matter Expert (SME) will involve supporting and leading on this at key touchpoints throughout to ensure successful completion of all TMF scoped deliverables. You’ll also have involvement in monthly project reviews evaluating operational and financial Key Performance Indicators, and will represent Syneos Health’s TMF Operations team at internal and sponsor teleconferences and F2F meetings.
Duties you will be involved in:
- Attendance at meetings (as TMF SME) including internal project team, sponsor and Trusted Process meetings in order to communicate and present TMF status updates, and seek relevant information to drive the execution/delivery of the TMF.
- Provision of recommendations on optimal TMF set-up in order to drive the TMF set-up, structure, and completeness reports.
- Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and documents any out-of-scope work in Change Notification Form/Change Orders as required.
- Collaboration with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an audit-ready state.
- Development of plans to increase compliance and following up on non-compliance, if applicable.
- Design and/or deliver study specific TMF training in various formats via teleconference, video conference, and/or in person to internal or external team members as applicable.
- Provision of regular feedback on TMF health/status (including actionable metrics) and/or generation of Completeness Reports to the Project Team. Presentation of monthly TMF status, risks, issues and associated actions for assigned projects during the Project Review Meeting (PRM).
- Preparation for and participation in audits/inspections to ensure ongoing readiness of the TMF.
- Representation of the TMF during Quality Finish Meetings, providing guidance to the Project Team and TMF Operations Team on performing the final QC/Completeness Review, and overseeing the TMF Shipment.
Performance of other work-related duties as assigned. Minimal travel may be required (up to 25%).
To succeed in this role you will need the following skills/experience:
- Undergraduate degree and good experience in a CRO or related field.
- Experience with leading/co-leading studies from award into maintenance through close-out 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.
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.