Manager, Clinical Monitoring

Role: Manager, Clinical Monitoring overseeing global/regional trial site management and monitoring activities in a biopharma setting, supporting clinical trial quality and compliance. Responsibilities include developing monitoring strategies, leading monitoring and oversight visits, managing CRO/CRAs, tracking performance metrics, and ensuring study documentation accuracy. The role involves mentoring CRAs, conducting performance assessments, coordinating training, and handling resource planning. Requirements: BS in biological sciences or related, 7+ years industry experience, including 2+ years in supervision; strong knowledge of GxP, ICH-GCP, and regulatory standards; proven leadership, communication, negotiation, and risk management skills. Preferred qualifications include experience in startup, execution, and closeout of clinical studies, risk-based monitoring approaches, and prior roles as Lead CRA or Trial Manager. High-value specifics: experience in endocrine disorders preferred, travel up to 30%, and involvement in clinical trials from start-up through closeout. Location: may involve travel; work environment includes desk work with some walking and lifting. The position offers a salary range of $132,000-$165,000, plus bonus, stock options, benefits, and 20 days PTO.