Study Start Up Lead
About this role
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.
Responsibilities
- ● 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.
About Roche
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.