Senior Project Manager, Clinical Operations

Surf Search Inc.; New York (NY); Remote; USD 120,000 - 160,000; Full time

Job summary

Surf Search Inc. asks for a Senior Project Manager, Clinical Operations to lead U.S. clinical studies for medical devices, focusing on enrollment, site performance, investigator engagement, and milestones.

This remote-based role requires regular travel across the U.S. and prefers East Coast candidates. You will collaborate with investigators, clinical experts, customers, and internal teams to drive study execution and strategy.

Qualifications

• Bachelor's degree in life sciences, nursing, engineering, or a related discipline; advanced degree preferred.
• 10+ years of clinical research or clinical operations experience with direct responsibility for clinical study execution.
• Strong experience managing medical device clinical studies, preferably Class II/III and interventional devices.
• 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.
• 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.

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.

Skills

Project management

Site engagement

Enrollment strategies

Vendor management

GCP/ICH knowledge

Communication

Problem-solving

Education

Bachelor's degree in life sciences, nursing, engineering, or related discipline

Advanced degree preferred

Tools

CTMS

EDC

Microsoft Office

Job description

The Senior Project Manager, Clinical Operations, will lead the execution of US clinical studies for medical device products, with a strong focus on enrollment, site performance, investigator engagement, and achievement of study milestones.

This highly site-facing role requires regular travel to clinical sites to identify and resolve operational challenges, improve enrollment, and strengthen study execution. The position will also contribute to clinical strategy and the development of new studies by working with investigators, clinical experts, customers, and internal stakeholders.

This is a remote-based role, with a preference for East Coast candidates.

Key Responsibilities of the Senior Project Manager, Clinical Operations:

• 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 of the Senior Project Manager, Clinical Operations:

• Bachelor's degree in life sciences, nursing, engineering, or a related discipline; advanced degree preferred.
• 10+ years of clinical research or clinical operations experience with direct responsibility for clinical study execution.
• Strong experience managing medical device clinical studies, preferably Class II/III and interventional devices.
• 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.

Occupational Code: 11-9121.01 - Clinical Research Coordinators