Country Study Start-Up Lead

3M HEALTHCARE; Madrid; Presencial; COP 309.237.000 - 436.570.000; Jornada completa

Descripción de la vacante

Roche is seeking a senior professional to lead the country study start-up for Spain, coordinating with cross-functional teams to ensure efficient site activation and regulatory compliance.

You will drive process improvements, manage submissions and amendments, and collaborate with regional and global teams to harmonize systems and timelines. The role requires strong communication, regulatory knowledge, and willingness to travel as needed.

Formación

• Degree in life sciences or related field. Postgraduate trials/clinical research degree desirable.
• Experience in clinical trial start-up in Spain and regulatory submissions.
• Proven track record in managing site relationships and multi-site trials.
• Strong knowledge of ICH-GCP, EU CTR, and local regulations.
• Fluent in English and Spanish; able to travel as needed.

Responsabilidades

• 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 and site levels.
• Collaborate with regional and global counterparts to harmonize systems and improve timelines.
• Oversee development and management of clinical trial submissions and amendments.

Conocimientos

Cross-functional collaboration

Communication skills

Bilingual English/Spanish

Educación

Life sciences degree

Postgraduate degree in clinical trials or clinical research

Descripción del empleo

Roche is seeking a senior professional to lead the country study start-up for Spain, coordinating with cross-functional teams to ensure efficient site activation and regulatory compliance.

You will drive process improvements, manage submissions and amendments, and collaborate with regional and global teams to harmonize systems and timelines. The role requires strong communication, regulatory knowledge, and willingness to travel as needed.