Senior Clinical Trials Operations Lead

Penfield Search Partners Ltd.; Fairfield (CT); Híbrido; USD 110 000 - 165 000; Tempo integral

Resumo da oferta

Penfield Search Partners Ltd. is partnering with a leading biopharmaceutical company to hire an experienced Clinical Trial Business Operations Manager.

The role focuses on managing and executing clinical trial activities in alignment with GCP, regulatory requirements, and study timelines. You will collaborate with clinical operations leadership and cross-functional teams to ensure high-quality deliverables, risk-managed planning, and on-time, within-budget study execution across regional

Qualificações

• Minimum 5 years of clinical trial management in pharma/biotech with trial logistics experience.
• Experience overseeing CROs and vendors with strong regulatory knowledge (ICH/GCP).
• Bachelor's degree in life sciences, healthcare, or related field.
• Ability to work in a matrixed team, demonstrate leadership and communication.

Responsabilidades

• Support COL and/or Sr. CTM with management and execution of clinical trial activities per GCP.
• Provide detailed regional oversight of trial activities and cross-functional coordination.
• Coordinate site feasibility, patient population access, and site selection decisions.
• Develop and review study documents including CRFs, informed consent forms, and regulatory submissions.
• Participate in RBQM/RBM activities and inspection readiness.

Conhecimentos

Clinical trial management

Leadership

Vendor management

Regulatory knowledge

Problem-solving

Communication

Formação académica

Bachelor's degree in life sciences or related field

Descrição da oferta de emprego

Penfield Search Partners Ltd. is partnering with a leading biopharmaceutical company to hire an experienced Clinical Trial Business Operations Manager.

The role focuses on managing and executing clinical trial activities in alignment with GCP, regulatory requirements, and study timelines. You will collaborate with clinical operations leadership and cross-functional teams to ensure high-quality deliverables, risk-managed planning, and on-time, within-budget study execution across regional