TMF Specialist (Contractor)

The Impact You’ll Make

Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a contract TMF Specialist to support the maintenance and enhance the quality of clinical trial TMFs. You can expect to perform quality reviews and gap assessments on existing TMFs and support the set-up of new TMFs. This role will support the management of TMF documentation issues throughout the lifecycle of assigned studies.In this role, you will:

• Support the development of key TMF implementation activities.  These will include authoring procedures, templates, and tools.  You will become familiar with study design so you can also guide study teams in establishing TMF plans and will be a key participant in defining Expected Document Lists (EDLs) for each study.
• Ensure TMF health throughout the study by uploading documents to the TMF and performing risk-based quality and completeness reviews of the TMF content.  Quality and completeness reviews will be done by document/TMF review and by monitoring metrics and trends as identified in relevant reports.  You will inform stakeholders of any missing documents and/or non-compliance with plans or regulations, then follow up to verify that the issue has been mitigated.  For unresolved issues, escalation may be necessary. 
• Maintain awareness of study events and the associated documentation requirements through collaboration with the Vendor or CRO and Study Team.  You will then assist the team in updating relevant TMF documents (i.e., TMF Plan, EDL).

Location:

This position will be remote or office based. 

The Team You’ll Join 

Reporting to a Director of Clinical Operations, you’ll be joining the Clinical Development team. You will work with the greater cross functional team collaborating across multiple clinical programs within Recursion. This high-performing team works together to progress our growing clinical portfolio at Recursion.

The Experience You’ll Need

• 3+ years of TMF experience required, including experience in study start-up, maintenance and closeout, and performing quality and completeness reviews. Previous experience with independently managing and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.
• Advanced experience in electronic TMF systems, Must have knowledge of Core, Country, and Site level essential documents both domestically and internationally.
• Key Competency Requirements: Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (E6(R2))
• Subject Matter Expert (SME) knowledge of clinical trial documentation, DIA Reference Model, clinical trial activities and related terminology.
• Ability to work up to 40 hours a week

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