Senior Clinical Trial Leader – IDE & Global Studies

Shifamed; Los Gatos (CA); Vor Ort; USD 140.000 - 180.000; Vollzeit

Zusammenfassung

Shifamed LLC is seeking a Sr. Clinical Trial Manager to own end-to-end execution of clinical studies across IDE pivotal trials, registries, and international studies. You will manage timelines, budgets, sites, vendors, and data quality, leveraging CROs for field execution.

Reporting to the Sr. Director of Clinical Affairs, you will lead start-up through closeout, ensuring compliance with ICH GCP and FDA regulations while driving efficiency in a lean, fast-paced clinical team.

Qualifikationen

• 7+ years managing medical device clinical trials, with hands-on experience across study start-up, monitoring oversight, and closeout.
• Experience selecting and managing CROs, EDC systems, and independent monitors; data management and vendor oversight.
• Demonstrated experience running FDA IDE studies; registries and international (OUS) studies is a strong plus.
• Startup mindset: capable of building processes and operating with limited supervision in a fast-paced environment.
• PMP certification or proficiency with project management tools (Smartsheet, MS Project) is a plus.

Aufgaben

• Own end-to-end execution of assigned clinical studies (IDE, registry, post-market, international) from start-up through closeout, ensuring on-time, on-budget, inspection-ready delivery.
• Lead study start-up activities: protocol, informed consent, CRFs; site identification, qualification, selection; regulatory submissions (IRB/EC).
• Develop and maintain study documents: clinical/investigational plans, monitoring plans, training & recruitment materials, study reports.
• Oversee CROs/CRAs; review monitoring reports; resolve site issues; sponsor oversight or co-monitoring visits as needed.
• Establish and maintain TMF; oversee EDC build, testing, and data quality across lifecycle.
• Manage clinical supply forecasting, IND/IDE accountability, and site payments.
• Drive enrollment against plan; identify and address barriers with sites and teams.
• Support CEC/DSMB activities and regulatory submission documents.

Kenntnisse

Clinical trial management

Regulatory compliance

Vendor management

Project management

FDA IDE experience

ICH GCP ISO 14155

Ausbildung

BA/BS in life sciences or engineering

Advanced degree preferred

Tools

Smartsheet

MS Project

EDC systems

Jobbeschreibung

Shifamed LLC is seeking a Sr. Clinical Trial Manager to own end-to-end execution of clinical studies across IDE pivotal trials, registries, and international studies. You will manage timelines, budgets, sites, vendors, and data quality, leveraging CROs for field execution.

Reporting to the Sr. Director of Clinical Affairs, you will lead start-up through closeout, ensuring compliance with ICH GCP and FDA regulations while driving efficiency in a lean, fast-paced clinical team.