TMF Manager

ProClinical Ltd
12 Jan 2018
11 Feb 2018
Contract Type
Full Time
ProClinical is seeking a TMF Manager for a Global Biotech, to be based in Berkshire on a permanent basis.

Job Responsibilties:

* Provide day to day document management support to Clinical Development and be an
* initial point of contact for Trial Master File (TMF) Process related questions
* Author, contribute to, maintain and implement TMF Management Controlled Documents
* and associated resources (e.g. training materials, knowledge databases)
* Administer on-site training, across Clinical Development, on the policies and procedures
* relative to and for document quality and process
* Perform and manage ad hoc TMF Quality Assessments
* Lead appropriate Clinical Development document-related Regulatory Inspection
* Readiness Activity
* Act as a system of record (i.e. eTMF) expert and an initial point of contact for system
* related questions
* Play a pivotal role in the generation, interpretation, cascade and escalation of metrics for
* the TMF
* Work with Strategic CRO Partners on the continued development of TMF and Record

Skills and Requirements:

* Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position
* Minimum 5 years pharmaceutical / biotechnology
* Minimum 3 years records management experience in a GCP-regulated environment and with Essential TMF Documents
* Strong interpersonal skills and ability to manage at all levels within a cross-functional organization through influence
* Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude
* Strong Regulatory knowledge, including Good Clinical Practices (GCP)
* Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred

To Apply:

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 call Matthew Pike on Phone number removed or upload your CV on our website - URL removed
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.