Senior Scientist, Clinical Research (Remote)

Merck KGaA Darmstadt Germany - Trenton, NJ

Full-time - Mid Level

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Senior Scientist in Clinical Research at Merck will provide biomarker project management and operational expertise to support cross-functional clinical teams. This role focuses on ensuring the timely and efficient delivery of biomarker operational aspects of clinical studies, primarily in immunology, while also supporting other disease areas as needed. The successful candidate will collaborate with various stakeholders to manage specimen collection, testing, and data delivery activities, while advocating for operational excellence in a fast-paced environment.

Responsibilities

• Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial execution.
• Act as the operational partner to the Biomarker scientific leads to implement strategies that drive the biomarker program forward.
• Co-author relevant biomarker sections of clinical study protocols.
• Manage specimen collection, handling, shipping, and storage guidelines in alignment with the Biomarker plan and clinical study protocol.
• Provide biomarker vendor assay statement of work and data transfer specifications to clinical teams.
• Transfer biomarker data to clinical data repository from external biomarker vendors in collaboration with data management.
• Design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors.
• Maintain and grow effective partnerships with external biomarker vendors and internal teams.
• Coordinate sample and assay logistics, serving as a key point of contact with vendors for timeline tracking, issue resolution, and risk mitigation.

Requirements

• Bachelor's in a scientific or technological field of study with five (5) years of relevant experience, or a Master's or higher degree with three (3) years of relevant experience.
• Project Management experience within the Science realm.

Nice-to-haves

• Drug discovery experience, including familiarity with clinical trial execution in Oncology studies.
• Biomarker assay experience including genomic/genetic, IHC, immunoassay, flow cytometry, mass spectrophotometry, and others.
• Formal Project Management certification.