Country Study Start-Up Lead — Accelerating Clinical Trials

F. Hoffmann-La Roche AG; Madrid; On-site; EUR 90,000 - 120,000; Full time

Job summary

Roche is seeking a lead for Country Study Start-Up within Global Clinical Operations to drive efficient initiation of clinical trials across Spain. You will coordinate with external stakeholders, manage regulatory submissions, and work with cross-functional teams to streamline processes and timelines.

You will influence budgeting, contracts, and country start-up activities, while traveling as needed to sites to ensure regulatory compliance and timely activation.

Qualifications

• Experience in clinical trial start-up in Spain.
• Regulatory submissions and cross-functional collaboration.
• Fluent in English and Spanish; strong communication skills.

Responsibilities

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

Skills

Clinical trial start-up experience

Regulatory submissions

Cross-functional collaboration

Communication skills

Travel flexibility

Education

MD/PhD/MA/MS/BA/BS in life sciences or related field

Job description

Roche is seeking a lead for Country Study Start-Up within Global Clinical Operations to drive efficient initiation of clinical trials across Spain. You will coordinate with external stakeholders, manage regulatory submissions, and work with cross-functional teams to streamline processes and timelines.

You will influence budgeting, contracts, and country start-up activities, while traveling as needed to sites to ensure regulatory compliance and timely activation.