The Clinical Study Manager is part of the Regulatory and Clinical Affairs organization which ensures that the internal and external work performed to develop our products is following Good Clinical Practice (GCP) requirements, applicable regulatory requirements (domestically and internationally) and is submitted to the FDA in a complete, accurate, and timely manner for approvals in support of the business units.
Your work will impact the quality of the FDA submissions and help secure the necessary approvals for our products to be marketed and reach the patients who will ultimately benefit from these companion diagnostics.
The primary role of this position is targeted toward Clinical Studies planning, core team support, and CRO Management.
typical roles and responsibilities for Clinical Study Manager
- Participate as Clinical Studies representative to project core teams
- Participate in lab assessment visits and lab selection process
- Work closely with core team and Regulatory Representative during the studies planning, coordination, and management phases.
- Document clinical studies plans/ reports for inclusion into the project Design History File (DHF)
- Interact as the primary clinical studies representative to pharmaceutical partners concerning study requirements
- Facilitate internal and external clinical studies preparation and planning meetings
- Interact as the primary interface between the company and CRO
- Ensure that CRO activities and timelines are in coordination with regulatory and project requirements
- Implement and document communication with CRO and laboratories to ensure project progress
- Real time escalation of Clinical studies issues to Project and Regulatory Management
- Update Clinical Department procedures as needed.
- Mentor/ train junior level CRA personnel.
Requirements for Clinical Study Manager – Life Sciences
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
- Working knowledge of Good Clinical Practices is required.
- Certification as a Clinical Research Professional (CCRP) is a plus
- If certification is not in place, class work/ course work in Good Clinical Practices is required.
- Minimum of 4 years working in the Diagnostics or Medical Device Industry. In Vitro diagnostic experience is a plus.
- A Minimum of 4 years demonstrated experience managing in house and/or external clinical studies.
- Experience working with multi-functional project teams is required.
- Computer literacy, including spreadsheet, database and word processing applications required.
Knowledge, Skills, Abilities
- Candidate must be an independent professional who proactively communicates frequently and effectively.
- Must be comfortable working on projects where the project and its team members may be located at another site
- Should be at ease with direct communication with internal project team members, external CROs and Pharmaceutical partners.
- Should be organized and able to work to on multiple projects with tight deadlines.
- Willing to travel away from home on an occasional basis.
- High energy level; positive attitude; works well under stress; assertive and effective communicator.
- Hands-on, action-oriented, and able to implement effectively.