Clinical Operations Manager

About the role

A strategic and hands-on Clinical Operations Manager responsible for overseeing clinical trials for medical devices while driving process remediation and operational excellence.

Responsibilities

• 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.
• 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.
• Remediate structure of Trial Master File(s) and as applicable records to ensure audit readiness/ preparedness across studies.
• Serve as point of contact for IRB/EC submissions and correspondence (including central IRB).
• Oversight 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-monitor the assigned clinical trial following company SOPs.
• Create and submit study-level regulatory documents.
• Contribute to validation plans and clinical performance study plans.
• Perform periodic quality control checks on the TMF.
• Proactively identify and manage study related risks.
• Develop and manage 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).
• Provide regular clinical program updates to executive leadership and project teams.
• Foster a culture of accountability and continuous improvement.

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.
• Demonstrated ability to lead teams and work in a fast-paced team environment.
• Excellent written and oral communication skills.