Study Start Up Lead

About the role

Roche/Genentech, within its Pharma Product Development Global Clinical Operations (PDG), is looking for a Study Start Up Lead to join its Country Study Start-Up team in Madrid. The role drives and facilitates the efficient initiation of clinical trials, working in a collaborative, cross-functional environment to help shape the country's clinical trial delivery strategy.

Key responsibilities

• Lead the country strategy for study start-up, driving efficiency, innovation and collaboration with external stakeholders.
• Oversee start-up operations to ensure timely and efficient site activation and regulatory compliance.
• Identify and lead opportunities for process automation, standardization and innovation at country and site level.
• Collaborate with regional and global counterparts to harmonize systems and improve timelines.
• Oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination.
• Provide strategic oversight of budgeting and contract management, including budget strategies and negotiations with internal and external stakeholders.
• Participate in external industry collaborations to influence the country's start-up environment.

Required profile

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field; a postgraduate degree in clinical trials or clinical research is highly desirable.
• Demonstrated experience in clinical trial start-up in Spain, regulatory submissions and cross-functional collaboration.
• Proven track record managing site relationships and complex clinical trial start-ups, such as at least 2 years as a Clinical Trial Monitor.
• Fluent written and spoken English and Spanish.
• Ability to manage multiple priorities in a fast-paced environment and to travel if needed.

Required skills

• Strong understanding of ICH-GCP, EU CTR and local regulatory environments.
• Excellent communication, interpersonal and problem-solving skills.