Study Start-Up Lead (SSUL)

The Position

Are you driven by the idea of delivering clinical trials that make a meaningful difference in patients’ lives? As the Study Start-Up Lead (SSUL), you will be a core member of the PDG Country Study Start-Up Team, driving the efficient delivery of innovative clinical trials across multiple therapeutic areas.

Your primary mission is to streamline and optimize study start-up processes, ensuring trials are executed seamlessly for patients, investigators, and site staff. You will achieve this by collaborating closely with local internal and external teams, global study teams, and Contract Research Organizations (CROs). This role is critical in driving process efficiency, fostering cross-functional teamwork, and embracing innovation to accelerate the clinical trial landscape.

Key Challenges & Strategic Focus

This dynamic role demands leadership in navigating a fast-paced, cross-functional environment:

• Strategic Leadership: Craft and execute country-level start-up strategies, balancing global alignment with local needs to deliver efficient, compliant, and patient-centric trials.
• Regulatory Excellence: Oversee clinical trial submissions, amendments, and regulatory challenges, ensuring adherence to global timelines and the evolving regulatory landscape.
• Innovation & Continuous Improvement: Identify opportunities for automation, process improvement, and harmonization across systems to accelerate study start-up timelines.
• Complex Stakeholder Collaboration: Liaise with Ethics Boards, Health Authorities, CROs, and key internal/external stakeholders. You will align priorities and share best practices to influence clinical trial policies both locally and globally.
• Navigating Complexity: Precisely manage site documentation, compliance, budgeting, and contract negotiation while fostering strong partnerships with government and institutional bodies.
• Expert Navigation: Serve as an expert in navigating complex regulatory environments and working within established frameworks such as ICH-GCP, EU CTR, and local regulatory provisions (e.g., IVDR and Ethics requirements).

Candidate Profile (Who You Are)

You are a visionary and strategic thinker with a passion for clinical trials and a commitment to making an impact.

Required Expertise and Skills

• Clinical Trial Expertise: Proven, hands-on experience in clinical trial start-up processes, regulatory submissions, and managing complex, multi-stakeholder projects.
• Process Innovation: A talent for identifying improvement opportunities, standardizing processes, and introducing innovative solutions to enhance efficiency.
• Leadership & Collaboration: Excellent ability to lead teams in a matrixed environment, collaborate effectively across local and global teams, and manage vendor/CRO relationships with ease.
• Regulatory Knowledge: Deep understanding of ICH-GCP, EU CTR, and local regulatory processes allows for navigation of complexities with precision.
• Communication: Possess excellent interpersonal skills and the ability to communicate clearly and influentially in global, cross-functional environments.
• Technical Acumen: Proficient in using clinical systems (e.g., Veeva Vault, CTIS, RIM) and confident in tackling challenges with an analytical mindset.
• Drive & Focus: Ability to independently collaborate, drive speed, ensure site excellence, and maintain quality and efficiency in both process and execution.

Qualifications

• A strong academic foundation: A degree in life sciences is mandatory, and a postgraduate degree is desirable.
• Fluency in English.
• Requires organizational excellence, attention to detail, and a collaborative, adaptive mindset.

Why Join Roche?

This is an opportunity to shape the future of a progressive, globally recognized organization. You will be empowered to make impactful decisions and contribute to life-changing healthcare solutions. At Roche, we foster a collaborative environment where every voice matters, driving innovation to ensure everyone has access to healthcare today and for generations to come.

Note that relocation benefits are not available for this role.

Roche is an Equal Opportunity Employer.