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...].