Clinical Trial Manager (Biomarkers)

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Title: Clinical Trial Manager
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have impact, and you’ll be supported in achieving your career goals.

• Complete clinical trial operations for the B·R·A·H·M·S biomarker clinical study program in the US
• Conduct national and regional activities aiming to generate supporting evidence for the clinical validity and utility of B·R·A·H·M·S biomarkers
• Work with experts in the field to design appropriate clinical study protocols for FDA registrations, new indications, use extension or use adoption of B·R·A·H·M·S biomarkers
• Review investigator-initiated study concepts keeping IP relevance in mind
• Provide clinical trial oversight for site selection and recruitment of prospective investigators for sponsored clinical trials and liaise with the study partners
• Manage the contracting process with external collaborators such as study sites and contract research organizations
• Curate critical metrics dashboard for clinical trial progress and provide status reports on clinical trial operations to leadership
• Create and track budget plans for clinical trial operations
• Create study materials and quality documentations according to internal GPD/SOPs and applicable national/international regulations
• Effectively partner with internal colleagues and external stakeholders in health economic and outcomes research evidence generation, including support for reimbursement and guidelines development and/or implementation
• Generate trial reports and contribute to the publication efforts in close collaboration with the Sr. Medical Affairs Manager and Medical Affairs Director
• Ensure scientific validity of Marketing and Sales materials as they relate to clinical studies