Contract CTA / TMF Associate

Proclinical is advertising an exciting opportunity for a Contract CTA/TMF Associate position, joining a pharmaceutical company in London. Our client is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. This is a rolling 6 month contracted position.

The CTA/TMF Associate will assist the Clinical Operations team to implement a TMF/eTMF from scratch and implement training cross-functionally to the team, including appropriate filing of all documentation. They will also provide support for execution of assigned studies to the Project Manager and Clinical Operations Team.

Job Responsibilities:

• Leading the development of TMF/Clinical Documentation systems and processes.
• Providing support with setting up, maintenance, and study close-out activities relating to the TMF, including archiving to a third-party vendor.
• Reviewing TMFs being held by CROs, paper, and eTMFs. This includes QC activities for completeness, correctness of the trial documentation, and well as submission in a timely manner.
• Acting as the main point of contract between the company and the CRO re: filing and archiving activities. Escalating issues/feedback to the company's team.
• Conducting study tracking support (e.g., start-up tracking, sample reconciliation, milestone tracking) and study updates.
• Acting as the company's Named Archivist, which involves archiving, retrieving and taking inventory of clinical trial documentation.
• Educating clinical teams or affiliated groups on TMF processes.
• Assisting with the preparation and organisation of internal/external meetings.
• Filing, tracking, and maintaining TMF assisting with inspection readiness activities.
• Ensuring timely study entry and updates to ClinicalTrials.gov.
• Designing and preparing study related materials for the training of internal and external staff.
• Assigning the correct training, equipment, and clinical/non-clinical supplies to sites and CRAS.
• Reviewing all Green Light Process (GLP) checklists on a site level and approving as required.

Skills and Requirements:

• A degree in a relevant science field.
• Demonstrable relevant experience.
• A strong understanding of medical terminology and clinical process.
• Demonstrable experience with filing and archiving clinical information.
• Excellent English oral and written skills.
• Excellent organisational and prioritisation skills with a great attention to detail.
• Proficiency with Microsoft Office.
• Strong communication, presentation, persuasion, and interpersonal skills.

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 +44 207 440 0639 or upload your CV on our website - www.Proclinical.com.

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.

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