Company: CK Clinical
Closing Date: 13 Dec 16
Salary (£): Negotiable
Lucy Stendall is recruiting for a Trial Master File Specialist to join a world leading research based pharmaceutical company at their site based in Uxbridge...
Lucy Stendall is recruiting for a Trial Master File Specialist to join a world leading research based pharmaceutical company at their site based in Uxbridge on a 6 month contract in the first instance.
This role is primarily accountable for providing operational support to study teams implementing the Trial Master File (TMF) process. You will work to a core set of activities according to the company's standard operating procedures, regulatory requirements and good clinical practice.
The main purpose of the role will be to
- Ensure that study teams are set up and supported to maintain an up-to-date and inspection ready TMF at all times.
- Make a significant contribution to implementation of elements of the strategic plan to meet the company's commitments and to focus the Pharma R&D organisation on consistent, readily accessible, inspection ready and available clinical documentation in the shape of a Trial Master File for every study.
- Provide operational TMF support on the company's interventional human subject research studies (including low interventional studies that require full adherence to ICH-GCP) sponsored by Pharma R&D or by a Third Party where Pharma R&D is subject to a service level agreement for the provision of clinical services.
- Serve as an expert point of contact in the business (e.g. functional lines in R&D, Local Operating Companies, sites and vendors) for TMF matters and liaise with internal and external partners to help improve study team's understanding of the challenges and associated solutions to ensure excellence in TMF inspection readiness on a day-to-day basis.
- Support the embedding and implementation of Pharma TMF and associated systems across Pharma R&D by working directly with Study Teams as they use the Pharma TMF system to ensure inspection readiness throughout the study lifecycle.
Further responsibilities will include:
- Drive the set up of the TMF and Global/Local TMF Plans with the Study Accountable Person (SAP) by: Supporting the SAP to create the Global Pharma TMF plan, Arrange and facilitate TMF kick-off meetings, write up meeting minutes and follow up on actions, Support Country Study Managers to create Local Pharma TMF Plans & Work with Business System Administrators to ensure artefact placeholders and cover pages in place in a timely manner.
- Ensure timely execution of the Global/Local TMF Plans
- Trigger the milestone TMF collation reviews (e.g. run eTMF tracking reports and distribute to study team members in functional lines, review the outcome and summarize actions for the SAP/team)
- Trigger the Pharma TMF system audit trail reviews and follow up on issues/actions with the SAP
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Knowledge and experience with the use of TMF systems and associated business processes & knowledge of the TMF Reference Model.
- Thorough understanding of the Clinical Development processes.
- Bachelors degree in scientific discipline and a proven working ability of understanding and interpreting regulations and implications for clinical information management requirements across Pharma R&D.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37579 in all correspondence.
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