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Clinical Trial Manager
HeartFlow, IncParticipates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks; Develops clinical trial timelines, enrollment proj…
Core Competencies
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Candidates should emphasize their expertise in managing clinical operational activities, ensuring compliance with regulatory standards, and leading process improvements in clinical research settings. Strong project management skills and the ability to collaborate effectively with diverse teams are essential for success in this role.
ATS Keywords
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About the role
Key responsibilities & impact- Oversee and manage all clinical operational activities at the trial and site level.
- Interact with Heartflow Clinical Research staff and collaborate with onsite and field staff, clinical research coordinators, principal investigators, and vendors.
- Ensure clinical studies meet or exceed timelines and maintain high quality standards.
- Participate in clinical research activities including management of clinical study sites, study documentation, vendor management, and project management tasks.
- Develop clinical trial timelines, enrollment projections, and instructional materials in support of trial execution.
- Lead process improvement activities within the department and cross-functionally, including SOP development.
- Conduct study start-up activities including the development of protocols and informed consent forms.
- Review site regulatory documents to ensure compliance with study requirements and GCPs.
- Maintain effective working relationships with investigators, research coordinators, and vendors.
- Perform other duties as required for successfully completing studies.
Requirements
What you’ll need- Bachelor’s degree in science or health related field.
- Demonstrated 5 years minimum relevant experience required.
- Experience in cardiovascular medical device clinical research a plus.
- Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations.
- Excellent written and oral English communication skills required.
- Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint.
- Ability to work in a smaller team environment with a willing, all hands on deck attitude.
- Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities.
- High attention to detail, accuracy, and quality, and able to effectively prioritize multiple projects.
Benefits
Comp & perks- Base salary compensation range of $95,000 to $125,000.
- Cash bonus.