The Clinical Trial Manager (CTM) - Investigator Initiated Studies is responsible for the oversight and management of all clinical operational activities for investigator initiated studies. The CTM will interact well with the HeartFlow Clinical Research staff and collaborate effectively with HeartFlow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture.
Job Responsibilities:
- Participates 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 projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
- Participates in and leads process improvement activities within the department and cross functionally, including SOP development.
- Conducts study start-up activities including leading study kick off meetings, contract management, and site onboarding and training.
- Reviews site regulatory documents (informed consents, IRB approvals, research agreements) as needed to ensure compliance with study requirements and GCPs.
- Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management.
- Track internal and external project deliverables to ensure they remain within the timeline and budget.
- Perform other duties as required for successfully completing studies, as necessary.
Skills Needed:- 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.
- Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
- Excellent written and oral English communication skills required.
- Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint
Educational Requirements & Work Experience:
- Bachelor's degree in science or health related field
- Demonstrated 5 years minimum relevant experience required
- Experience managing investigator initiated studies a plus
- Experience in cardiovascular medical device clinical research a plus
A reasonable estimate of the base salary compensation range is $90,000 to $130,000 and cash bonus. #LI-IB1
