Clinical Trial Manager, Investigator Initiated Studies

Heartflow; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Heartflow is seeking a Clinical Trial Manager (CTM) for Investigator Initiated Studies to oversee clinical operational activities. You will collaborate with HeartFlow Clinical Research, onsite and field staff, coordinators, PIs, and vendors to ensure studies meet timelines and quality standards.

The role requires experience in clinical research study execution, exceptional organizational skills, and the ability to thrive in a fast-paced startup culture. Salary ranges are provided in the ad.

Qualifications

• Bachelor’s degree in science or health related field.
• Minimum 5 years of relevant clinical research experience.
• Experience managing investigator initiated studies is a plus.
• Experience in cardiovascular medical device clinical research is a plus.

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

Team collaboration

Multitasking

Attention to detail

Regulatory knowledge

English communication

MS Office

Education

Bachelor's degree in science or health related field

Tools

Microsoft Office

Job description

Heartflow is seeking a Clinical Trial Manager (CTM) for Investigator Initiated Studies to oversee clinical operational activities. You will collaborate with HeartFlow Clinical Research, onsite and field staff, coordinators, PIs, and vendors to ensure studies meet timelines and quality standards.

The role requires experience in clinical research study execution, exceptional organizational skills, and the ability to thrive in a fast-paced startup culture. Salary ranges are provided in the ad.