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