*Candidate can work at Mercks Rahway, NJ OR Upper Gwynedd, PA location*
The Biomarker Operations team at Merck partners with clinical organizations to ensure biomarker assays in clinical trials are conducted efficiently, accurately, and in compliance with quality, ethical, and regulatory standards. This role offers the opportunity to leverage scientific knowledge and clinical trial experience while working cross-functionally with internal teams, central labs, biorepositories, and external vendors. The Biomarker Operations Specialist will play a key role in the operational setup, management, and execution of biomarker specimen collection to support clinical research programs.
Responsibilities
• Support the operational setup and management of biomarker specimens collected during clinical trials.
• Ensure biomarker-related information is accurately captured in study protocols, specimen logistics workflows, and clinical/lab instruction manuals.
• Serve as the subject matter expert for biomarker specimen activities throughout protocol planning and execution.
• Collaborate with central labs, biorepositories, and external vendors to support biomarker operations.
• Track and communicate project timelines, status, risks, and issues to study teams.
• Partner with cross-functional clinical teams to achieve project goals and ensure operational efficiency.
• Maintain strong communication and relationships with internal stakeholders and external partners.
• Lead and facilitate biomarker-related operations planning meetings.
Education
• Bachelor’s, Master’s, or higher degree in a scientific or technological field required.
Experience
• 2–3 years of experience in clinical trial setup and execution required.
• Experience in clinical study operations and project management strongly preferred.
• Familiarity with basic lab techniques in the life sciences is an advantage.
Additional Information
• HYBRID - 3 days in office
• Proficiency in MS Office suite required; experience with document review software a plus.
• Strong organizational skills, problem-solving abilities, and adaptability in a fast-paced environment.
• Ability to manage stakeholder needs, resolve study-related issues, and shift priorities as needed.
