Sr Clinical Trial Manager Biomarker

Description

bioMerieux is a global leader in the field of in vitro diagnostics, dedicated to improving public health and improving patient outcomes through innovative diagnostic solutions. . We are seeking a highly skilled and motivated Sr Clinical Trial Manager to join our team and lead clinical studies focused on cardiac biomarkers in an FDA-regulated environment.

Job Description:

We are seeking an experienced and highly motivated Senior Clinical Trial Manager to lead and oversee clinical studies focused on cardiac biomarkers in an FDA-regulated environment. The role involves planning, coordinating, and managing studies from initiation to completion, ensuring compliance with FDA regulations and GCP guidelines. Key responsibilities include developing study protocols, managing relationships with clinical research sites and CROs, and monitoring study progress. The ideal candidate will have a minimum of 7 years of experience in clinical trial management and strong project management skills. Previous experience in management of clinical studies to support FDA clearance for cardiac biomarkers (e.g. hs-cTnI, NT-proBNP, D-Dimer) is required.

Responsibilities:

• Plan, coordinate, and manage clinical studies from initiation to completion, ensuring compliance with FDA regulations and Good Clinical Practice (GCP) guidelines.
• Develop and implement study protocols, informed consent forms, and other essential documents.
• Oversee site selection, initiation, monitoring, and close-out activities.
• Ensure accurate and timely data collection, entry, and reporting.
• Manage relationships with CROs, clinical research sites, investigators, and other stakeholders.
• Monitor study progress and address any issues that arise, ensuring adherence to timelines and budgets.
• Prepare and present trial status reports to senior management and regulatory authorities.
• Collaborate with cross-functional teams.
• Maintain up-to-date knowledge of industry trends, regulatory requirements, and advancements in cardiac biomarkers.
• Writes final study reports and contributes to regulatory submission documentation

Key Skills and Qualifications:

• Bachelor's degree in life sciences, nursing, or a related field (Master's or PhD preferred).
• Minimum of 7 years of experience in clinical trial management, with at least 4 recent years of focus on cardiac biomarkers.
• Experience with cardiac biomarker assays and related technologies.
• In-depth knowledge of FDA regulations, GCP guidelines, and clinical trial processes.
• Strong project management skills.
• Excellent oral and written communication and interpersonal skills, with the ability to work effectively with diverse teams.
• Detail-oriented with strong organizational and problem-solving abilities.
• Ability to travel (domestic and international) as needed for site visits and meetings.