Reference: PW 6721
Closing Date: 14 Nov 16
Salary (£): Competitive
Global Pharma company
Role with broad scope and wider ranging responsibilities
Line management responsibility for one
· The TMF manager is responsible for overseeing the daily document management activities ensuring the integrity of the Trial Master File (TMF). Functions include:
o coordinating Quality Control reviews of study TMFs to ensure they are of the highest quality and inspection ready, and meet compliance specifications according to regional regulations and ICH guidelines;
o managing the activities associated with the TMF business process, including continuous improvement activities and metrics, and archiving;
o assisting with the oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training;
o liaising with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF
· The TMF manager will serve as Lead for one of the main processes within the department. This will include oversight and management of the end to end activities involved in the process
· The TMF manager will supervise at least one subordinate at same location.
· Additionally, the TMF manager will support the Head of TMF Process Management and QC in other areas within the department’s remit.
· The TMF Manager will be required to work collaboratively with group members and contribute to positive team relationships, both locally and globally. This role will lead initiatives and serve as a subject matter expert in TMF Operations.
QUALIFICATIONS / EXPERIENCE REQUIRED:
· Education to B.Sc. level or equivalent, preferably in a scientific discipline
· Demonstrated experience in the pharmaceutical industry, preferably in a clinical development/operations role or in regulatory operations would be considered
· Experience with Clinical Document Management, TMF, and/or Clinical Quality Control
· Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines)
· Must have strong knowledge of and be able to differentiate all key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents).
· Must have good understanding of the clinical development process
· Knowledge/understanding of technologies to support document collection and archiving
· Supervisory/line management or mentoring experience preferred
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please click the Apply for Job button quoting reference PW 6721.
Quality, TMF, Trial master file, quality operations, clinical operations, regulatory operations, clin ops, reg ops, ICH, GCP, Clinical Document Management, document management, ICFs, CRFs, Protocols, QC, quality control, TMF Process Management, eTMF, GCP QC, clinical quality control,
AXESS has been operating since 1990
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