Study Start Up Lead

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

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.