Trial Master File Lead
- Clinical Research, Clinical Administrator, Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Services, Clinical Supplies, Clinical Trials Manager / Administrator, Drug Safety, Feasibility, Pharmacoeconomics, Pharmacovigilance, Study Site Coordinator, Study Start Up, Data Management / Statistics, Clinical Data Management, Informatics, Statistics, Medical Affairs, Medical Advisor, Quality, QA / QC, Quality Validation Engineer, R & D , Pre - clinical, Regulatory Affairs
Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.
A career with Syneos Health means your everyday work improves patients’ lives around the world.
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
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.
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. #LI-LM1