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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we aredetermined to transform drug development and realize our Pharma Ambition to deliver 20transformative medicines addressing diseases with the highest societal burden by 2029.As a key member of our Country Study Start-Up team, you will drive and facilitate the efficientinitiation of clinical trials, ultimately helping to deliver innovative treatments to patients. You willwork in a highly collaborative and cross-functional environment, where you have the opportunityto influence and shape our clinical trial delivery strategy. This is a unique opportunity to use yourexpertise to make a meaningful impact by ensuring seamless trial execution for patients,investigators, and clinical site staff.

The Role

• Lead Country Strategy: You will lead the country strategy for study start-up, drivingefficiency, innovation, and collaboration with external stakeholders.
• Oversee Operations: You will oversee start-up operations to ensure timely and efficientsite activation and regulatory compliance.
• Drive Process Improvements: You will identify and lead opportunities for processautomation, standardization, and innovation at both the country and site levels.
• Collaborate and Harmonize: You will collaborate with regional and global counterpartsto harmonize systems and improve timelines.
• Manage Clinical Trial Submissions: You will oversee the development andmanagement of clinical trial submissions and amendments, ensuring regulatorycoordination.
• Strategize on Budget ; Contracts: You will provide strategic oversight for all aspectsof budgeting and contract management, including developing budget strategies andnegotiating with internal and external stakeholders.
• Influence the Environment: You will participate in external industry collaborations toinfluence the countrys start-up environment.

Who You Are

• You have a 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.
• You have demonstrated experience in clinical trial start-up in Spain, regulatorysubmissions, and cross-functional collaboration.
• Proven track record in managing site relationships with a customer centric mindset andmanaging complex clinical trials start-up (e.g. at least 2-year previous experience as aClinical Trial Monitor).
• You possess a strong understanding of ICH-GCP, EU CTR, and local regulatoryenvironments.
• You have excellent communication, interpersonal, and problem-solving skills, with acollaborative mindset.
• You are fluent in both written and spoken English, and in Spanish.
• Ability to manage multiple priorities and work in a fast-paced, dynamic environment.
• Ability to travel if needed.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Roche is an Equal Opportunity Employer.