Senior Manager, Clinical Operations

Role: Senior Manager, Clinical Operations overseeing the planning, execution, and oversight of Phase I-IV clinical trials supporting biopharma development programs. Responsibilities include leading or supporting trial management, developing study plans, managing vendor relationships, ensuring compliance with ICH-GCP and regulatory standards, and collaborating cross-functionally with internal teams such as Clinical Development, Data Management, and Regulatory Affairs. The role entails oversight of site selection, study start-up, monitoring, and close-out activities, alongside budget and timeline management. Leadership duties may include managing direct reports, mentoring junior staff, and fostering a high-performing team environment. Requirements: Bachelor’s degree in a scientific discipline, minimum of 7 years’ experience in clinical research within biotech, pharma, or CRO settings, with expertise in global clinical trial regulations and GxP standards. Preferred skills include experience with rare disease trials, risk-based quality management, and working with global investigative sites. The role requires approximately 20% travel and involves working within a regulated environment supporting Phase I-IV trials, with a focus on quality, timelines, and budget adherence.