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Job Details

TMF Management Associate - Marlow

Company: CK Clinical
Location: Marlow
Reference: CL40446
Closing Date: 20 Nov 17
Type: Contract
Salary (£): 20,000 - 30,000
Benefits:

Job Summary:

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...

Requirements:

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 6 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 organisational 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

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and 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 CL40446 in all correspondence.

Apply for this job: TMF Management Associate - Marlow

Contact Information:

Address:  Head Office
9 High Street
Stevenage
Hertfordshire
SG1 3BG
England
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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