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

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 youll 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 youll 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. Heres 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: Youre 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 youre 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.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.