Clinical Trials Expert

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

In Roches Pharmaceutical Research and Early Development organisation (pRED) we make transformative medicines for patients to tackle some of the worlds 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 pREDs 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. SPOs 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 COs 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 methodologiesincluding project conceptualisation situational analysis solution design implementation and continuous improvementand 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 youre 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 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.

Employment Type : Full-Time
Experience: years
Vacancy: 1