Strategic Country Start-Up Lead, Clinical Trials

Roche; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

Roche in Spain seeks a Country Study Start-Up leader to drive country strategy for trial initiation, optimize site activation timelines, and ensure regulatory alignment across studies, investigators and sites.

You will collaborate with regional/global teams, manage budget-related aspects, and promote process improvements across the country start-up environment to enable efficient delivery of clinical trials.

Qualifications

• Degree in life sciences or related field; postgraduate trials/clinical research desirable.
• Experience in Spain with clinical trial start-up, regulatory submissions and cross-functional teams.
• Strong understanding of ICH-GCP, EU CTR and local regulations.

Responsibilities

• Lead country strategy for study start-up and drive efficiency.
• Oversee start-up operations, site activation, and regulatory compliance.
• Identify and lead opportunities for process automation and standardization.
• Collaborate with regional and global teams to harmonize systems and timelines.
• Manage development and management of trial submissions and amendments.

Skills

Clinical trial start-up

Regulatory submissions

Cross-functional collaboration

I​CH-GCP knowledge

EU CTR awareness

Fluent English & Spanish

Education

Life sciences degree (MD/PhD/BA/BS)

Job description

Roche in Spain seeks a Country Study Start-Up leader to drive country strategy for trial initiation, optimize site activation timelines, and ensure regulatory alignment across studies, investigators and sites.

You will collaborate with regional/global teams, manage budget-related aspects, and promote process improvements across the country start-up environment to enable efficient delivery of clinical trials.