Clinical Research Engagement Lead

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The Clinical Research Engagement Lead (CREL) at Roche plays a crucial role in strengthening site engagement, supporting the success of clinical trials by ensuring effective communication and collaboration with clinical trial sites, and adding value to Roche’s portfolio, from early to late-stage development and all Roche assets. The CREL focuses on supporting streamlined experience for sites and engaging operational site stakeholders on Disease Area (DA)-study level topics.

The CREL fosters an environment of trust and partnership by maintaining open communication and providing strategic input and operational support to investigators and other external stakeholders. The CREL integrates clinical research knowledge, expertise in clinical trial operations, DA portfolio knowledge, cultural awareness and local language(s) management to deliver a site-facing customer experience focused on efficiency and speed. The CREL focus is on clinical operations with strong links to other key functions throughout the organization that may engage sites.

The CREL convenes a Local Site Engagement Community (Local Medical Affairs, PDG cTAL, Field Medical, etc.), that will coordinate to anticipate and support site needs to enhance their experience as they participate in Roche trials. The CREL collaborates with the Contract Research Organisation (CRO) team in managing relationships with trial sites throughout the clinical trial lifecycle, ensuring alignment toward the shared goal of trial success.

Effective site engagement ensures Roche is perceived as a reliable and preferred partner by clinical trial sites and championing a ONE Roche approach. By developing and executing tailored site engagement strategies and plans, the CREL fosters trust and operational excellence, thus expediting trial progress, enhancing site satisfaction, and improving overall clinical trial outcomes, fostering relationships with sites, even in complex environments.

It is expected that the CREL fully understands site infrastructure and ways of working to best co‑create and monitor site engagement. The CREL proactively and transparently provides feedback on sites / investigator performance regarding clinical operational delivery.

• The CREL develops and plans the country‑level Site Engagement DA Strategy for Clinical Operations, aligning with the iCOP and the Local Site Engagement Community, taking into consideration the DA maturity level in the country and the portfolio across the DA. In that capacity, the CREL contributes to deliver on aligned clinical DA priorities, and relay / flag any potential mismatch in priorities between the site and internal stakeholders.
• The CREL contributes to investment decisions in Principal Investigators and/or sites to support the overall DA strategy for Clinical Operations.
• Early and strategic site engagement (in person or remotely) during landscaping (DA level) or during the clinical trial set up phase enables the identification of the most suitable sites and investigators for early engagement (e.g. protocol concept stage or robust synopsis / draft protocol review) and for study conduct (e.g. speed in recruitment). By providing valuable insights into the country, protocol and site feasibility and informing strategic decisions, the CREL supports optimal study settings, benefiting both the program goals and patients, thereby improving trial quality and efficiency.
• Strategic Site Engagement Support: in collaboration with other Roche functions and the CRO, proactive engagement and support during the study conduct and closure phases address potential site…