Here at Syneos Health we are currently recruiting for Trial Master File Specialist to be part of a team which is 100% sponsor dedicated. In this role you will be working at the heart of clinical trials supporting the study team on a variety of TMF Duties.
This role is 100% sponsor dedicated and will be based at the client’s offices in central London.
Working as a Trial Master File (TMF) Specialist you will be responsible for:
- Provision of operational and administrative support for TMF Study Management.
- Supporting the study team with planning and execution of TMF management related activities to ensure the ongoing health and compliance of the TMF.
- Taking ownership of the TMF plan – setting up and creating plan for new studies, reviewing on-going contributions to TMF for studies in maintenance - and taking action to address any gaps, issues and risks.
- Acting as a point of contact for TMF related queries, and leading/delivering training as needed.
- Working to timelines and in line with company SOP's.
To be considered for the role candidates should have:
- Undergraduate degree in Life Sciences and a minimum of 2 years of industry experience.
- Significant experience in TMF.
- Experience of using Veeva Vault eTMF system.
- In-depth knowledge of GCP and ICH guidelines.
- Above-average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills.
- Proactive approach and the 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 our website.
Disclaimer: 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.