020 3198 1686

TMF Management Associate in Marlow, Buckinghamshire, England

Marlow, Buckinghamshire, England
£ 27000 - 28000 Per year
Job type
Job Id
Posted on
28 Apr 2017
View all Jobs from CK Group

About the Role:

Lucy Stendall is recruiting for a TMF Management Associate II to join a multi speciality global pharmaceutical company at their site based in Marlow on a 12 month fixed term contract.

The main purpose of the role will be to:

• Provide administrative assistance in document receipt, preparation, scanning/loading, naming and filing and tracking of key records and documents for the conduct of clinical research studies

• Serve as the central receipt function for clinical documents from various sources

• Work closely with study teams to assist with timely uploading of clinical documentation to the company's Trial Master Files (TMFs) and to ensure accuracy, consistency and quality

• Be responsible for high level quality control reviews of TMF documents

• Assist with TMF document maintenance and tracking activities

• Align execution activities with agreed upon project priorities, timing and quality specifications

· Assist in maintenance of TMF study documentation throughout the life of the study (i.e., from study initiation to close out).

· Coordinate receipt of hard copy and electronic clinical trial documents from cross-functional customers, such as internal project teams and departments, by way of study-specific email boxes, investigator research sites, and investigator portals.

· Perform scanning of clinical trial documents into the company's electronic data management system (EDMS) as required,.

· Perform high level quality control reviews of documents for completeness, legibility and logistic checks.

· File TMF records in appropriate TMF locations or ensure updated study documents are appropriately filed and stored in the study TMF.

· Conduct periodic QC checks and end of study activities for TMF outsourced to third parties.

· Coordinate with teammates to identify quality / performance trends and contributes to determining remedial action.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

· Experience working in Clinical Records Management or Clinical Trial Management.

· Sound regulatory knowledge, e.g. 21 CFR Parts 312, 812, EU Directive and ICH.

· Understanding of Trial Master File (TMF) requirements.

· Bachelor's degree or equivalent ideally a Life Science Degree or relevant Industry recognized qualification preferred.

· Excellent organizational and filing skills

· Able to handle and prioritise multiple tasks simultaneously

· Must be able to routinely meet tight deadlines and meet high quality standards

· Good knowledge of Clinical Practices, ICH guidelines, Data protection law

For more information or to apply for this position, please contact Lucy Stendall on [... Click Apply...]733 or by email on [... Click Apply...].


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