bioMérieux 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.
Location: SLC or STL, with generous relocation package included.Remote work option within the US, subject to discussion.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 documentationKey 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.
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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).