Senior Project Manager, Clinical Operations

Surf Search is seeking a Senior Project Manager, Clinical Operations to lead the execution of U.S. clinical studies for medical device products. The role focuses on enrollment, site performance, investigator engagement, study milestones, clinical strategy, and development of new studies, with regular travel to clinical sites.

Responsibilities:

• Lead U.S. clinical studies from feasibility and site activation through enrollment, follow-up, database lock, and close-out
• Drive enrollment, site engagement, study performance, timelines, budgets, and risk management
• Manage CROs, core laboratories, vendors, and clinical sites
• Build relationships with investigators, clinical experts, and research teams and conduct regular site visits
• Collaborate with Clinical, Regulatory, Quality, Data Management, Biostatistics, and Commercial teams
• Support development of new clinical study concepts and evidence-generation strategies
• Ensure studies comply with protocols, GCP/ICH requirements, FDA regulations, and applicable procedures

Requirements:

• 10+ years of clinical research or clinical operations experience with direct responsibility for clinical study execution
• Experience managing U.S. clinical studies, including IDEs, post-market studies, registries, and/or investigator-initiated studies
• Demonstrated success driving site engagement, enrollment, and study performance
• Experience managing CROs, core laboratories, and other clinical vendors, including contracts, budgets, timelines, and performance
• Experience working directly with investigators, clinical experts, customers, and internal stakeholders to develop or support new clinical study concepts
• Strong knowledge of GCP/ICH, FDA requirements, IDE/IRB processes, and clinical research standards
• Strong project management skills across scope, timelines, budgets, resources, risks, and deliverables
• Excellent communication, relationship-building, and problem-solving skills
• Ability to manage multiple studies and competing priorities in a fast-paced environment
• Proficiency with CTMS, EDC, and Microsoft Office
• Willingness to travel extensively throughout the U.S
• advanced degree preferred
• Strong experience managing medical device clinical studies, preferably Class II/III and interventional devices