Remote Senior Clinical Project Manager, Medical Devices

Clinnect; United States; A distancia; USD 96.000 - 165.000; Jornada completa

Descripción de la vacante

Clinnect is seeking a Senior Clinical Project Manager to lead planning, execution, and oversight of medical device clinical programs. You will manage timelines, budgets, vendor oversight, site management, risk mitigation, and regulatory compliance in a fast-paced development environment.

This fully remote 12-month renewable contract favors candidates in EST/CST time zones. The role requires hands-on experience with IDE, post-market, ICH-GCP, ISO 14155, and working with cross-functional teams

Formación

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, Healthcare, or related discipline.
• 5+ years of clinical operations or clinical project management in medical device, biotech, pharma, or CRO.
• Direct experience managing medical device clinical trials (IDE, post-market, observational, or registry-based).
• Strong understanding of FDA regulations, ICH‑GCP, ISO 14155, global clinical research requirements.

Responsabilidades

• Lead operational execution of domestic and global medical device clinical studies from start-up to closeout.
• Develop and manage study timelines, budgets, forecasts, and resource plans.
• Oversee CROs, vendors, core laboratories, and external partners.
• Monitor enrollment progress, data quality, and operational metrics; address risks.
• Ensure trial conduct complies with regulations and quality systems.

Conocimientos

Leadership

Communication

Stakeholder management

Travel willingness

Problem solving

Educación

Bachelor's degree in Life Sciences or related

Advanced degree (MS, MPH, RN, PharmD)

Herramientas

EDC systems

CTMS platforms

Descripción del empleo

Clinnect is seeking a Senior Clinical Project Manager to lead planning, execution, and oversight of medical device clinical programs. You will manage timelines, budgets, vendor oversight, site management, risk mitigation, and regulatory compliance in a fast-paced development environment.

This fully remote 12-month renewable contract favors candidates in EST/CST time zones. The role requires hands-on experience with IDE, post-market, ICH-GCP, ISO 14155, and working with cross-functional teams