TMF Specialist
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The Opportunity
Description
We're looking for a TMF Specialist, working in Biotechnology/Medical Devices industry in 2550 Stanwell Dr., Concord, California, United States.- Works with multi-functional study teams to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
- Creates and maintains study-specific TMF Management Plan.
- Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.
- Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- 3 plus years of relevant records management/ TMF management experience
- Comprehensive understanding of the clinical study phases involved in drug development and their corresponding records requirements
- Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines related to Clinical Document Management. Experience in medical device and compliance with ISO 14155 desired
- Ability to collaborate with study teams to establish and determine TMF requirements
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Apply Now
