Senior Associate Trial Master File
An internationally renowned pharmaceutical company is seeking to recruit a Senior Associate - Trial Master File (TMF) to their office in the UK. The organisation works across a range of therapeutic sectors, including oncology, neurology, and gastroenterology. This position is an exciting opportunity to work with a global establishment that discovers and develops innovative therapies to help address unmet medical needs.
- Lead various TMF activities associated with TMF Management, including TMF setup, eTMF query resolution, eTMF user support and training.
- Assist with developing training materials and conducting TMF training for global eTMF users; assist with managing the activities of TMF associate and/or contract staff
- Perform the activities associated with quality control reviews of study TMFs to ensure adherence to SOPs and regulatory requirements and that the TMF is inspection ready; these activities include:
- preparing the Study QC Review Plan and conducting associated risk assessments
- perform QC reviews; prepare QC Findings reports; assist with analyzing trends and preparing metrics
- Provide feedback to project teams and /or management for the correction and resolution of document quality issues, TMF completeness, and timely submission of documents to the TMF
- Assist with oversight of the eTMF vendor to ensure service meets expectations.
- Interact with eTMF vendor, company functional areas, and/or CROs to resolve eTMF queries, issues, and questions related to the eTMF business process.
- Collaborate with study teams to monitor the eTMFs for completeness and quality.
- Coordinate the activities related to archiving of TMF documents, including obtaining approval from the study team, notifying the eTMF vendor, and maintaining electronic logs which contain the location of study documents.
- Oversee the shipping, retrieval, and tracking of documents approved for archiving to off-site storage.
- Assist with maintaining and updating the TMF file structure and business rules.
- Conduct continuous improvement and monitoring of the business environment to anticipate future areas of risk and need for process changes.
- Collect and evaluate recommendations for improvement from the user community.
- Facilitate the writing or update of departmental SOPs and SWPs as needed.
- Initiate improvements to departmental SOPs and SWPs.
Skills and Requirements:
- Education to B.Sc. level or equivalent, preferably in a scientific discipline.
- Strong background (4+ years) in the pharmaceutical industry, preferably in regulatory operations or clinical development/operations.
- Demonstrated experience with Clinical Document Management, TMF/eTMF, and/or Clinical Quality Control desired.
- Must have strong knowledge of and be able to differentiate all key clinical trial essential documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents).
- Must have good understanding of the clinical development process, including regulatory documents and regulatory requirements (including ICH and GCP guidelines).
- Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.