What are the responsibilities and job description for the Senior Clinical Trial Manager - Med Device / Diagnostics position at Research & Development Institute, Inc.?
Research & Development Institute (RDI) is a tech-enabled CRO that helps In Vitro Diagnostic manufacturers who struggle to get FDA clearance for their products by sourcing the blood samples they desperately need through physicians and labs.
RDI received a large investment in 2021 that has allowed it to transition from a founder led business into a world-class diagnostic CRO with scientific experts and a CLIA lab that allow it to manage larger and more profitable projects.
RDI is seeking a Senior Clinical Trial Manager to be responsible for overall strategy, planning and execution of its projects, from start to finish. Ideally, this candidate has experience in medical device: diagnostic trials and either can leverage the appropriate scientific and operational expertise to design the study, identify and recruit sites and oversee the team to ensure our projects stay on track and that our clients are satisfied.
This is a long-term career position with significant room for growth as our company expands nationwide. RDI is changing the landscape for diagnostic CROs and is on an exciting growth trajectory.
Given the growth stage of our company, the best candidate will be passionate about our mission to become the leading diagnostic CRO and will love all aspects of building a business (including the intensity, market competition and being part of a close-knit & small team.)
Responsibilities
- Analyze client requests for samples, lab work, or full-service trial management to determine feasibility
- Work with SVP of Ops to develop budget proposals and study budgets for sites & labs
- Identify and/or recruit clinical sites / labs where necessary to participate in studies
- Design protocols, CRFs, lab manuals, SIVs, and any other documentation required to manage the study and deliver the required data to the client
- Work with the SVP of Ops to ensure client and site satisfaction
- Provide clinical trial expertise and oversight to team of Project Assistants and Lab Assistants
- Ensure studies are closed out and data delivered to client
Requirements
- Track record of managing successful sample collection or medical device trials on time and within budget