Website Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to e… read moreach patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology; Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. Roche Products (Pty) Ltd – South Africa Diagnostics Division PO Box 1927 9 Will Scarlet Road, Ferndale 2125 Randburg
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.
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Apply via company website ( http://www.roche.com ) or