Job Information
Just in Time GCP eClinical (TMF) Records Supervisor in Warrington, Pennsylvania
Why choose Just in Time GCP as the next step in your career?
Because we help organizations achieve operational excellence! Our team of professionals assist biotech and pharma companies develop and streamline compliant processes, proactively prepare for regulatory inspections, implement and optimize eClinical technologies, and provide an efficient and effective resourcing strategy for Sponsor oversight and TMF management. We take great pride in knowing that our GCP compliance support plays a role in helping clients achieve their goal of getting critical therapies to market and changing patients' lives.
We are a fast-growing industry leader in the TMF (Trial Master File) Services, Inspection Readiness and Clinical Compliance (GCP) Consulting space. In fact, we have been recognized by INC500 for the past 3 years, as well as one of JP Morgan's 50 Fast Growing Woman Owned/Led Businesses for the previous 2 years and most recently an INC500 Best Workplace. Our Founder & CEO was named EY Entrepreneur of The Year® 2022 Greater Philadelphia Award winner.
Are you looking to join an organization where you can make an immediate impact and champion the value of inspection readiness and GCP Compliance? Then you are 'Just in Time' to be a part of our amazing growth!
What you will do -- Highlights of responsibilities include:
- Supervises team of Records Associates and ensures quality standards of work product for team.
- Assigns workload for Records Associates.
- Proactively evaluates performance and provides guidance for professional development, recognizes achievements, and addresses areas needing improvement. Effectively resolves issues and conflicts.
- Provides direction in alignment with the corporate strategy and core values.
- Performs quality oversight reviews.
- Identifies trends and issues of TMF record review.
- Manages assignment of reconciliation and/or remediation work.
To succeed in this position, the ideal candidate would have:
- Bachelor's degree and a minimum of 3 years of related experience or equivalent combination of education and experience.
- Strong proficiency in MS Office Suite.
- Understanding of the TMF lifecycle and document management process (Paper/Electronic).
- Proficiency working with a variety of eClinical systems and ability to learn new technologies.
- Expert understanding of the TMF Reference Model structure.