Clinical Operations Manager

A strategic and hands-on Clinical Operations Manager responsible for overseeing clinical trials for medical devices while driving process remediation and operational excellence. This role requires a creative, resourceful, and flexible leader who can prioritize effectively, build structure where needed, and ensure clinical studies are conducted in full compliance with applicable regulatory standards.

Clinical Trial Leadership & Execution

• Manage sponsor-led clinical trials for medical devices across the U.S. and EU.
• Ensure all clinical studies are conducted in adherence to study protocols, ICH/GCP guidelines, and region specific regulations.
• Direct protocol development and finalization in collaboration with cross-functional teams.

Process Improvement & TMF Remediation

• Assess, remediate, and optimize clinical processes and work instructions to align with regulatory requirements, industry best practices, and organizational needs.
• Assess Trial Master File(s) against applicable regulations and industry best practices.  As needed remediate structure of Trial Master File(s) and as applicable records to ensure audit readiness/ preparedness across studies.

Regulatory & Compliance Oversight

• Serve as point of contact for IRB/EC submissions and correspondence (including central IRBs).
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs.
• Oversee preparation and submission of study-level regulatory documents
• Contribute to validation plans and clinical performance study plans.
• Perform periodic QC of the TMF

Site & Study Management

• Proactive identification and management of study related risks
• Responsible for developing and managing study related plans, processes including; Investigator agreements (CTA), CRFs, monitoring plan, data management, safety monitoring
• Lead development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements.
• Contribute to site identification, feasibility, and selection for clinical studies.
• Oversee site initiation, monitoring, and close-out activities (SQV, SIV, IMV, COV) as required.
• Develop and deliver training materials for internal teams, CROs, and study sites (e.g., protocols, device training, SIV presentations).

Leadership & Communication

• Provide regular clinical program updates to executive leadership and project teams.
• Foster a culture of accountability and continuous improvement.
• All other duties as assigned

Qualifications

• Bachelor’s degree or equivalent in life science
• Minimum of 7+ years preferred of clinical project management experience in conducting clinical trials in sponsor medical device organization, preferably Class III devices
• A solid understanding of the ICH guidelines/GCP
• Experience interacting with regulators, including FDA
• Ability to travel to visit clinical sites and for study meetings. Amount will vary upon project needs
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Ability to successfully engage and work collaboratively with sites and internal teams
• Excellent written and oral communication skills