Clinical Affairs Manager, in vitro diagnostics

This position is part of the Regulatory and Clinical Affairs organization which ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, 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. 

Discover Impactful Work:

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. 

A Day in the Life:

The primary role of this position is targeted toward Clinical Studies planning, core team support, and CRO Management. In this role, the primary responsibilities include: 

• Participate as a clinical study representative for project core teams. 
• Participate in lab assessment visits and lab selection process. 
• Work closely with the core team and regulatory representative during the studies' planning, coordination, and management phases. 
• Document clinical studies plans/ reports for inclusion into the Design History File (DHF) project.
• Interact as the primary clinical studies representative to Pharmaceutical partners concerning IVD study requirements. 
• Facilitate internal and external clinical studies preparation and planning meetings. 
• Interact as the primary interface between the company and CRO to ensure that CRO activities and timelines are in coordination with regulatory and project requirements. 
• Real time elevation of Clinical studies issues to Project and Regulatory Management. 
• Mentor/ train junior-level personnel. 

Keys to Success:

Education and Experience 

• A B.Sc. degree in biology, chemistry, bio-engineering, or related science is required.  
• Solid understanding of Good Clinical Practices is required. 
• 4+ years working in the In Vitro Diagnostic or Medical Device Industry; companion Diagnostic experience is a plus. 
• 4+ years of demonstrated experience managing in-house and/or external clinical studies preferred.
• 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 strongly preferred.
• Experience working with multi-functional project teams is required. 
• Digital literacy, including spreadsheet, database and word processing applications required. 

Knowledge, Skills, Abilities 

• Ability to work on projects where the project and its team members may be located at other sites. 
• Should be at ease with direct communication with internal project team members, external CROs and Pharmaceutical partners. 
• Willing to travel away from home on an occasional basis. 
• High energy level; positive attitude; works well under stress; assertive and effective communicator. 

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!