Principal Safety Committee Specialist - Adjudication

Thermo Fisher Scientific

Full-time - Senior

Remote

Computer and Electronic Product Manufacturing

About the position

The Principal Safety Committee Specialist - Adjudication is responsible for overseeing the day-to-day activities of Clinical Endpoint Committees (CEC) and Data Safety Monitoring Boards (DSMB) in a highly regulated environment. This role requires advanced knowledge of procedures and electronic platforms used for communication with these committees, as well as collaboration with various stakeholders including project teams, data management, and external clients. The specialist will also mentor less experienced staff and act as a primary point of contact in the absence of the manager.

Responsibilities

• Oversee day-to-day CEC/DSMB activities independently.
• Troubleshoot and resolve project issues, identifying areas for improvement.
• Serve as the primary point of contact in the absence of the manager and mentor less experienced staff.
• Initiate CEC/DSMB study start-up and close-out activities.
• Perform day-to-day CEC/DSMB activities using expert knowledge of committee processes.
• Review adjudication/DSMB publications to stay updated on regulations and practices.
• Maintain medical understanding of applicable therapeutic areas and disease states.
• Prepare and QC CEC dossier compilation and submission.
• Maintain secure files for DSMB unblinded data.
• Assist with project implementation and coordination, including presentations at meetings.
• Participate in departmental initiatives and serve as a subject matter expert.

Requirements

• Bachelor's degree or equivalent relevant qualification.
• 8+ years of relevant experience in clinical research or related field.
• Excellent understanding of pathophysiology and disease processes.
• Expertise in relevant therapeutic areas for CEC and/or DSMB review.
• Advanced critical thinking and problem-solving skills.
• Solid project management skills with the ability to manage multiple projects.
• Ability to motivate and mentor less experienced staff.
• Proficient in complex clinical study administration, including budget activities.
• Excellent oral and written communication skills.
• Advanced computer skills and proficiency in Microsoft Office products.
• Thorough understanding of global regulatory requirements and compliance.

Nice-to-haves

• Experience with electronic adjudication systems.
• Familiarity with audit preparation and representation in meetings.

Benefits

• Health insurance coverage
• Flexible work schedule
• Professional development opportunities