Clinical Trial Manager - Investigator-Initiated Studies

Heartflow; Orlando (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Heartflow is seeking a Clinical Trial Manager (CTM) - Investigator Initiated Studies to oversee clinical operational activities for investigator initiated studies. The CTM will work with Heartflow Clinical Research staff, onsite and field staff, coordinators, principal investigators, and vendors to ensure studies meet timelines and quality.

The successful candidate will have 5+ years of clinical research experience, knowledge of ICH and FDA/European requirements, and strong organizational skills

Qualifications

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

Responsibilities

• Participates in clinical research activities including management of clinical study sites, 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

Clinical trial management

Investigator Initiated Studies

Vendor management

Project coordination

ICH/GCP knowledge

FDA/European regulatory knowledge

English communication

MS Office proficiency

Education

Bachelor's degree in science or health related field

Tools

Microsoft Office

Job description

Heartflow is seeking a Clinical Trial Manager (CTM) - Investigator Initiated Studies to oversee clinical operational activities for investigator initiated studies. The CTM will work with Heartflow Clinical Research staff, onsite and field staff, coordinators, principal investigators, and vendors to ensure studies meet timelines and quality.

The successful candidate will have 5+ years of clinical research experience, knowledge of ICH and FDA/European requirements, and strong organizational skills