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The Position In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility, and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.
Strategy, Portfolio & Operations (SPO) is a unified function that serves as the strategic and operational backbone enabling pRED's strategy from lab to clinic. Operating under a dynamic Chapter Model, SPO centralises specialised skills across critical areas including Sites & Lab Services, Program & Project Management, Strategy, Clinical Operations, External Operations, Capability Development, Core Lab Technology Platforms (360Labs) and Asset Team Leadership. SPO’s mission is to drive enterprise value creation by delivering operational excellence and accelerating portfolio productivity. As a trusted partner, SPO fosters a culture of collaboration and accountability to ensure pRED transitions assets smoothly from early research to late-stage development.
At Roche Pharma Research and Early Development Clinical Operations (pRED CO), we are determined to transform early drug development and realise our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029.
The Opportunity
As part of the CO Community, the Clinical Trial Expert is accountable for a range of end to end study-level activities from systems set up to close out during the execution of trial(s).S/he is responsible for the delivery of operational systems and technical activities (e.g. eCOA, IxRS) in support of the Study and Programme delivery within timelines, budget, quality, while contributing towards the CO North Star of improving productivity and approaching study delivery from a patient centric mindset. The Postholder is accountable for delivering strategic components within their area of expertise that improve CO's productivity metrics. The role also requires enterprise-wide interconnectivity, networking, and monitoring of the internal and external environments.
In this position you will:
• Ensure the Clinical Operations organisation achieves and maintains a sustainable high level of portfolio delivery performance by implementing and maintaining study-specific solutions that deliver on the CO goals and objectives in your domain of expertise (e.g. IxRS, eCOA).
• Lead the implementation of systems maintenance, tools and reports required across the clinical trial life cycle (eCOA, IxRS, etc). Coordinate components of study startup, including input into / ownership of requests for proposal, authoring of documents and potentially site personnel training.
• With a strong background in trial system implementation and execution, you contribute to specific study strategies pertaining to your domain of expertise
• Establish and maintain optimal relationships with key internal and external partners and stakeholder groups.
• Contribute to the development and maintenance of relevant study oversight documentations/charters, processes and best practices as needed and represent pRED at cross-enterprise CO forums
• In your relevant domain of expertise, track study progress and address issues that may come up in close collaboration with study teams, affiliates, sites, and CROs as appropriate. Collaborate with stakeholders in generating relevant reports and KPIs to monitor trial progress. Identify signals and systematic areas for improvement at an Enterprise level.
• Establish standard approaches and provide support across the clinical portfolio in a range of activities such as Training Materials, Processes, SOPs, etc
Who You Are
• You are talented, passionate, and inspired by our mission, fitting perfectly into our collaborative, patient-centric, and entrepreneurial spirit; you want to make a difference and find excitement in innovating practices, therapeutics, and processes.
• You hold a university degree (or equivalent experience, preferably in life sciences) and possess deep experience in the pharmaceutical/healthcare industry and drug development (therapeutic area a plus), alongside a solid understanding of the clinical trial environment, ICH-GCP, and lifecycle sequence/interdependencies.
• You are highly experienced in clinical trial management tools, systems, and their interdependencies, specifically including IxRS, eCOA, centralised endpoint review (such as images, ECG, etc.), and digital biomarkers.
• You possess a solid grounding in business performance improvement methodologies—including project conceptualisation, situational analysis, solution design, implementation, and continuous improvement—and have the ability to collaborate with a range of stakeholders to implement the strategic direction for early development clinical studies.
• You find passion in achieving successful outcomes by leading, coaching, and inspiring others, while thriving in fast-paced, ambiguous, and highly collaborative environments where you can think on your feet, show a growth mindset, and embrace learning through experience.
• You bring strong problem-solving, analytical, negotiation, and interpersonal skills (both written and oral), and you feel completely comfortable travelling internationally based on specific program needs.
At Roche, we aim high to deliver life-changing healthcare solutions. If you’re ready to make a meaningful impact on patients and healthcare systems worldwide, this is the place for you.
Who we are 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.