Senior Study Lead / Clinical Operations Manager

About This Role

This highly operational, field-oriented role involves supporting and driving clinical trial operations across the United States and Canada. The successful candidate will take ownership of study execution, working directly with clinical trial sites, investigators, study teams, and hospital stakeholders, with a major component involving the formal and motivational aspects of starting up and driving new clinical trial centers.

Responsibilities

• Drive and manage the operational progress of clinical studies at the site level
• Support the start-up, activation, and ongoing management of new clinical trial centers
• Take a hands-on operational role in an ongoing FDA IDE clinical trial
• Ensure studies progress according to project plans, timelines, budgets, and required quality standards
• Work closely with the study CRO while maintaining strong sponsor-side oversight and accountability
• Establish close working relationships with study teams, screening teams, Principal Investigators, Key Opinion Leaders, and ICU medical staff
• Motivate and engage clinical sites to maintain study momentum, screening, and enrollment
• Ensure clear communication and prompt follow-up with sites and internal stakeholders
• Support clinical protocols, study documentation, regulatory requirements, and clinical data-related activities
• Ensure compliance with applicable FDA requirements and ISO 14155 clinical trial Good Clinical Practice
• Collaborate closely with cross-functional team members, scientists, and external clinical partners throughout all study phases
• Travel regularly to clinical trial sites throughout the United States and Canada

Requirements

• Direct FDA clinical trial experience
• Held an operational or full-responsibility role on at least one FDA-regulated clinical trial
• Demonstrated hands-on clinical trial operations and/or study management experience, including responsibility for keeping studies on track
• Working knowledge of ISO 14155 and clinical trial Good Clinical Practice
• Strong clinical/scientific writing, documentation, and data-analysis capabilities
• Scientific educational background (medical, life sciences, or biology backgrounds preferred; other relevant scientific disciplines may be considered)
• Ability and willingness to travel extensively throughout the United States and Canada, including occasional weekends and, when required, 2–3 consecutive weeks on-site
• Ability to work effectively and confidently with investigators, clinical research teams, and senior hospital stakeholders
• Highly proactive, fast-paced, and driven working style with excellent follow-through

Nice to have: