Senior Remote Clinical Trial Operations Leader

Penfield Search Partners Ltd.; Fairfield (CT); A distancia; USD 140.000 - 180.000; Jornada completa

Descripción de la vacante

Penfield Search Partners Ltd. partners with a leading biopharmaceutical company to recruit an experienced clinical trial management professional who will lead and oversee global trial operations, ensuring studies are executed on time, within budget, and in compliance with GCP.

You will work with cross‑functional teams, CROs, and vendors to drive site activation, enrollment milestones, risk management, and inspection readiness, while mentoring teams and aligning with strategic objectives.

Formación

• Minimum 7 years of clinical trial management experience in pharma/biotech.
• Experience coaching and mentoring to support leadership development.
• Experience in rare diseases and/or orphan indications preferred.
• Experience managing global CROs and complex early‑phase studies.
• Thorough understanding of drug development, ICH/GCP and local regulations.

Responsabilidades

• Leads and coordinates management of all clinical trial activities in compliance with GCP and regulations.
• Oversees regional/global trial activities, targeting site activation and enrollment milestones.
• Manages cross‑functional study teams with effective communication and risk management.
• Develops detailed project plans and provides regular status updates to senior management.
• Reviews CRFs, IRB applications, recruitment materials, and study documents.
• Collaborates with CROs and Legal to ensure IRB/Ethics alignment.
• Supports RBQM, RBM, and data integrity initiatives throughout lifecycle.

Conocimientos

Clinical trial management

Team leadership

Vendor management

GCP/ICH knowledge

Global trial experience

RBQM/RBM knowledge

Educación

Bachelor's degree in life sciences

Descripción del empleo

Penfield Search Partners Ltd. partners with a leading biopharmaceutical company to recruit an experienced clinical trial management professional who will lead and oversee global trial operations, ensuring studies are executed on time, within budget, and in compliance with GCP.

You will work with cross‑functional teams, CROs, and vendors to drive site activation, enrollment milestones, risk management, and inspection readiness, while mentoring teams and aligning with strategic objectives.