FDA IDE Clinical Operations Lead (Field Trials)

Groom & Associés / Associates; United States; Remote; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Groom & Associates seeks a highly driven Senior Study Lead / Clinical Operations Manager to lead clinical trial operations across the United States and Canada, with a strong FDA IDE trial background. This home-based role involves extensive travel and hands-on site management, startup activation of centers, and collaboration with investigators, CROs and hospital staff.

Ideal candidates bring direct FDA experience, ISO 14155 familiarity and proactive communication, with travel up to 60% across the

Qualifikationen

• Direct FDA clinical trial experience is mandatory; hands-on operation on FDA-regulated trials preferred.
• Experience in FDA IDE / investigational medical device trials highly valued.
• Hands-on clinical trial operations and/or study management with strong documentation.
• Working knowledge of ISO 14155 and GCP.
• Strong scientific writing, data-analysis and documentation skills.

Aufgaben

• Drive operational progress of clinical studies at the site level.
• Support the start-up, activation and ongoing management of new clinical trial centers.
• Take a hands-on operational role in an ongoing FDA IDE clinical trial.
• Ensure studies progress according to project plans, timelines, budgets and quality standards.
• Work closely with the CRO while maintaining sponsor-side oversight.
• Establish relationships with study teams, investigators and ICU staff.
• Motivate sites to maintain screening and enrollment momentum.
• Ensure clear communication with sites and internal stakeholders.
• Support regulatory, data-related activities and study documentation.
• Ensure FDA requirements and ISO 14155 compliance.
• Collaborate with cross-functional teams and external partners.
• Travel regularly to sites across the United States and Canada.

Kenntnisse

FDA IDE experience

Clinical operations

Site management

Regulatory writing

Excellent communication

Travel readiness

Ausbildung

Scientific degree (medical/life sciences)

Jobbeschreibung

Groom & Associates seeks a highly driven Senior Study Lead / Clinical Operations Manager to lead clinical trial operations across the United States and Canada, with a strong FDA IDE trial background. This home-based role involves extensive travel and hands-on site management, startup activation of centers, and collaboration with investigators, CROs and hospital staff.

Ideal candidates bring direct FDA experience, ISO 14155 familiarity and proactive communication, with travel up to 60% across the