Study Start Up Lead

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

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 are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative 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 efficient initiation of clinical trials, ultimately helping to deliver innovative treatments to patients. You will work in a highly collaborative and cross-functional environment, where you have the opportunity to influence and shape our clinical trial delivery strategy. This is a unique opportunity to use your expertise 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, driving efficiency, innovation, and collaboration with external stakeholders.
• Oversee Operations: You will oversee start-up operations to ensure timely and efficient site activation and regulatory compliance.
• Drive Process Improvements: You will identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels.
• Collaborate and Harmonize: You will collaborate with regional and global counterparts to harmonize systems and improve timelines.
• Manage Clinical Trial Submissions: You will oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination.
• Strategize on Budget ; Contracts: You will provide strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating with internal and external stakeholders.
• Influence the Environment: You will participate in external industry collaborations to influence 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, regulatory submissions, and cross-functional collaboration.
• Proven track record in managing site relationships with a customer centric mindset and managing complex clinical trials start-up (e.g. at least 2-year previous experience as a Clinical Trial Monitor).
• You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• You have excellent communication, interpersonal, and problem-solving skills, with a collaborative 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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.