Executive Director, Clinical Strategy & Delivery

Premier Research; España; Presencial; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Senior Director, Clinical Strategy and Delivery to lead the Clinical Management team. You will help translate breakthrough science into medicines, devices, and diagnostics while driving RBM strategy and risk management.

With 12+ years in clinical research and 5+ years in leadership, you will guide start-up to close-out activities, oversee monitoring approaches, and collaborate with internal and external partners to deliver high-quality results.

Formación

• Bachelor’s degree in a related field or equivalent.
• 12+ years of clinical research experience with 5+ years in Clinical Trial Manager/Clinical Lead or Project Management.
• Expert knowledge of GCP and ICH E6 R2 guidelines and regulatory requirements.
• Experience implementing Risk Based Monitoring methodologies.
• Strong understanding of all aspects of clinical operations from start-up to close-out.
• Expertise with central monitoring approaches and systems.

Responsabilidades

• Participates in Proposal Development for Clinical Operations, shaping RBM strategy.
• Supports commercial activities such as Bid Defense meetings, representing clinical operations and RBM components.
• Collaborates with SSU staff to keep start-up activities on schedule and escalates delays.
• Creates and oversees monitoring strategy for internal teams and sponsors with justification for chosen approach.
• Maintains knowledge of industry trends and regulatory framework.
• Evaluates RACT for quality and ICH compliance, and participates in risk assessment meetings.
• Oversees management of protocol execution risks and closes loop on issue resolution.
• Coordinates with internal and external vendors to operationalize the monitoring strategy.

Conocimientos

GCP & ICH E6 R2

Risk Based Monitoring

Clinical operations delivery

Project management

Budget/financial management

Line management

Educación

Bachelor’s degree in related field

Herramientas

Central monitoring tools

Regulatory systems

Descripción del empleo

Premier Research is seeking a Senior Director, Clinical Strategy and Delivery to lead the Clinical Management team. You will help translate breakthrough science into medicines, devices, and diagnostics while driving RBM strategy and risk management.

With 12+ years in clinical research and 5+ years in leadership, you will guide start-up to close-out activities, oversee monitoring approaches, and collaborate with internal and external partners to deliver high-quality results.