Clinical Trial Manager / Director

Job Overview: Waters Medical Systems seeking a Clinical Trial Manager or Director to lead premarket and postmarket studies for organ-preservation and perfusion technologies, generating reliable evidence for U.S. regulatory submissions and clinical adoption. Reporting to the SVP & General Manager, North America, with a strong dotted line to the Head of Global Regulatory in France, you will work with investigators and U.S. and France-based teams.

Clinical Strategy and Evidence: Lead study feasibility, protocols and evidence plans with investigators, Regulatory Affairs and biostatisticians; define endpoints, study design, timelines and resources. Prepare clinical content for FDA Pre-Submissions, IDE applications and De Novo, 510(k) and PMA submissions, as applicable. Work closely with Regulatory Affairs on regulatory strategy and formal submissions.

Trial Execution and Oversight: Own multicenter studies from site selection, IRB submissions and activation through enrollment, monitoring, database lock and final reporting. Oversee data quality, protocol compliance, safety escalation and inspection-ready trial records; resolve site and study issues as needed, promptly. Manage CROs, vendors, budgets and timelines; maintain sponsor oversight and report milestones, and risks. Coordinate study reports, publications and scientific advisory board activities; build practical study processes with Clinical, Regulatory, Quality and R&D colleagues. Required Qualifications8–10 years of progressive clinical research experience, with substantial medical-device trial experience and ownership of multicenter studies from start-up through closeout. Proven delivery of clinical evidence for U.S. submissions, with practical knowledge of FDA De Novo, 510(k) and PMA pathways. Experience succesfully managing investigators, CROs, vendors, budgets and timelines, including prospective trials and postmarket evidence generation. Bachelor’s degree in life sciences, biomedical engineering or a related discipline. Master's or PhD degree preferred. Must be legally authorized to work in the United States without employer sponsorship. Home location in the Central or Eastern U.S. time zones, near a major airport.

Note: candidates not meeting these minimum qualifications will not be considered. Skills and Working StyleStrong trial-design and data-interpretation skills; effective collaboration with biostatisticians. Working knowledge of device GCP, ISO 14155, applicable ICH guidance, FDA human-subject protection, IRB and IDE requirements, informed consent and patient-data protection. Highly effective project management skills to organize and succesfully drive definition, execution and completion of clinical studies with multiple internal and external stakeholders -- researchers, administration, RA, FDA.Clear English communication and effective collaboration with physicians, research sites and international teams. Self-directed and resourceful in a lean, entrepreneurial organization. Transplant or perfusion experience is highly desirable. Location and TravelHome-based in the U.S. Central or Eastern time zone, near a major airport. Up to 25% travel, primarily U.S., with occasional international travel and early video meetings with France. Ability to meet hospital and research-site access requirements, with reasonable accommodation.

Compensation and Benefits: Base salary of $150,000–$200,000, depending on experience, qualifications, and location, plus an annual incentive opportunity and medical, dental and 401(k) benefits.

About Waters Medical Systems: Learn more at www.wtrs.com.Waters Medical Systems is an equal opportunity employer committed to an inclusive workplace and nondiscrimination on any basis protected by law.