Contract TMF Manager (home-based)

Proclinical are recruiting a Contract TMF Manager for a mid-size pharmaceuticals organisation advancing in ground-breaking new class of medicines.

Responsibilities:

• Support eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding.
• Support TMF review process by working closely with study teams, CROs and Vendors.
• Support the management and tracking of TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies TMF Archiving.
• Support and/or deliver training across the company, CRO and Vendors on the policies and procedures relative to and for TMF management.
• Act as Subject Matter Expert for eTMF management.
• Ensure suitable reports and outputs are built to support TMF Quality.
• Ensure Study EDLs and Milestones are configured and maintained.
• Ensure the CRO's portion of the TMF is processed in a timely and controlled manner.
• Oversee the management of ask TMF mailbox and FAQ log TMF Quality.
• Oversee the Set-up of TMF paper folders and management of inventory trackers.
• Oversee the preparation of TMF records (paper and electronic) for long-term, off-site archival in compliance with company procedures, GCP and other relevant global regulatory requirements.
• Oversee the quality checks and retrievals testing of TMF records from long-term archival.
• Create and manage Study TMF Filing plan with input from Study team.
• Provide day to day document management support.
• Perform and manage TMF Quality reviews and drive for constant inspection readiness of TMFs.
• Serve as point of contact and support study teams for resolution of TMF-related queries or quality issues.
• Act as point of contact to support TMF audits and inspections as required Paper TMF.
• Participate in independent audits of external archive facilities, as applicable Process Improvement and Training.
• Author, contribute to, maintain and implement TMF Management Controlled Documents and associated resources (e.g. training materials, knowledge databases).
• Foster positive relationships with external vendors and internal clinical development areas.
• Work with Strategic CRO Partners on the continued development of TMF and Record Management practices and expectations.

Skills & Responsibilities:

• A Bachelor's Degree or comparable with substantial related experience in the pharmaceutical / biotechnology business including records management experience in a GCP-regulated environment.
• Strong working knowledge of the TMF Reference Model.
• Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF.
• Experience of electronic document management system(s) and Veeva eTMF preferred.
• Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred.
• Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude.
• Strong interpersonal skills and ability to manage at all levels within a cross[1]functional organization through influence.
• Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
• Ability to handle a high volume of complex tasks within a given timeline.

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 +44 203 7440 0639.

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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