Clinical Operations Manager
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Job Location:
Martinez, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Site & Study Management
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.
- 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.
- 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).
- Provide regular clinical program updates to executive leadership and project teams.
- Foster a culture of accountability and continuous improvement.
- All other duties as assigned
- Bachelors 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
Required Experience:
Manager
Key Skills
About Company
Seraph 100 Microbind Affinity Blood Filter is a revolutionary hemoperfusion medical device that addresses unmet clinical needs in treating bloodstream infections and reducing pathogens
