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