Study Start-Up Lead (SSUL) at Roche

The Position

• Are you driven by the idea of delivering clinical trials that make a meaningful difference in the lives of patients? As part of our PDG Country Study Start-Up Team, you'll be at the forefront of enabling innovative clinical trial delivery across multiple therapeutic areas. Your mission will be to streamline and optimize study start-up processes, ensuring trials are executed seamlessly for patients, investigators, and site staff. By working collaboratively with local internal and external teams, global study teams, and CROs, you’ll play a pivotal role in shaping a future where groundbreaking therapies reach patients faster.
• This is your opportunity to take the lead on driving process efficiency, fostering cross-functional teamwork, and embracing innovation to advance the clinical trial landscape.
• The grading range for these roles falls within the SE5-SE6 Range.

Key Challenges

• Strategic Leadership in Study Start-Up: You will craft and execute country-level start-up strategies, balancing global alignment and local needs to deliver efficient, compliant, and patient-centric trials.
• Regulatory Excellence: Overseeing clinical trial submissions, amendments, and regulatory challenges while ensuring adherence to global timelines and the ever-evolving regulatory landscape.
• Driving Innovation and Continuous Improvement: Identifying opportunities for automation, process improvement, and harmonization across systems to accelerate study start-up timelines.
• Complex Stakeholder Collaboration: Liaising with Ethics Boards, Health Authorities, CROs, and key internal/external stakeholders to align on priorities, sharing best practices to influence clinical trial policies globally and locally.
• Navigating Complexity with Precision: Managing site documentation, compliance, budgeting, and contract negotiation while fostering strong government and institutional partnerships.
• Is an expert in navigating complex regulatory environments and working within frameworks like ICH-GCP , EU CTR and local Regulatory provisions like IVDR and Ethics requirements.
• This dynamic role demands someone who thrives in a fast-paced, cross-functional environment and possesses the skills to lead through challenges with confidence.

Who You Are as Our Ideal Candidate

You are a visionary and strategic thinker with a passion for clinical trials and making an impact. Here’s what sets you apart:

• Clinical Trial Expertise: You bring hands-on experience in clinical trial start-up processes, regulatory submissions, and managing complex, multi-stakeholder projects.
• A Catalyst for Innovation: You have a knack for identifying improvement opportunities, standardizing processes, and introducing innovative solutions to improve efficiency.
• Leadership & Collaboration: You excel at leading teams in a matrixed environment, collaborating across local and global teams, and managing vendor and CRO relationships with ease.
• Regulatory Know-How: Your deep understanding of ICH-GCP, EU CTR, and local regulatory processes allows you to navigate complexities with precision.
• Communication Pro: You possess excellent interpersonal skills and the ability to communicate clearly in global, cross-functional environments.
• Tech-Savvy Problem Solver: You’re confident using clinical systems (e.g., Veeva Vault, CTIS, RIM) and thrive on tackling challenges with an analytical mindset.
• Ability to independently collaborate, drive and focus on speed, site excellence, Quality and efficiency of both process and execution is key!
• With a strong academic foundation (a degree in life sciences is a must, and a postgraduate degree is desirable), you pair your qualifications with organizational excellence, attention to detail, and a collaborative, adaptive mindset. If you’re fluent in English and passionate about driving change in clinical trials, this is your chance to make an impact that truly matters.
• Note that relocation benefits are not available for this role.