Barb Mercier is an experienced clinical research leader, currently serving as Manager of Clinical Research Associates at NAMSA, with over 25 years in the medical device industry. She has supported global trials in cardiovascular, neurology, peripheral vascular, and wound care. Barb oversees site management activities related to site start-up, manages performance of the internal Clinical Research Associate team, and contributes to metrics-driven strategies that accelerate site activation and improve operational efficiency. Her expertise includes clinical trial agreement negotiations, site budget development, and core lab and data management. Barb has contributed to successful clinical programs at Boston Scientific and Medtronic and supported site startup activities at multiple early-stage biotech companies. Her experience spans fast-paced environments requiring adaptability and cross-functional coordination, with collaboration across teams in North America, Europe, and the Middle East.
CORE COMPETENCIES
- Providing leadership and mentoring to the Clinical Research Associates team, fostering team development and performance
- Oversaw site start-up processes including IRB submissions, informed consent reviews, and recruitment material preparation
- Supported negotiations for Clinical Trial Agreements and study budgets, including drafting amendments
- Managed core lab operations—including echocardiology, cardiopulmonary exercise, Holter monitoring, and blood biospecimen analysis—while collaborating with vendors to ensure data reconciliation and compliance
- Developed and reviewed Standard Operating Procedures to maintain regulatory compliance and streamline operations
- Contributed to process improvements in site start-up workflows and template development, resulting in a more streamlined and efficient site activation approach
- Conducted on-site qualification and monitoring visits to ensure site readiness and protocol adherence
- Performed data management activities including CTMS training, case report form creation, data review, and database validation
- Administered clinical study payments, tracked accruals, and managed subject stipends and IRB-related fees
- Coordinated Investigator and Research Coordinator meetings to promote collaboration and study success
RECENT PROJECTS
- Contributed to initiatives improving site activation and selection strategy.
- Supported development of sponsor-facing tools and templates and process improvements, helping streamline workflows.
