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The Position

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 Roches 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.

Key Responsibilities

Site Engagement

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.

Site Engagement Strategy

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 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 needs promptly and ensure sustained site motivation and performance. The CREL can also come in support to Study Teams organizing motivational visits to boost recruitment (in collaboration with other Roche functions / CRO as needed) or to help address other significant site performance issues. By maintaining ongoing contact visiting sites as needed and responding swiftly the CREL preserves beneficial relationships with sites thus safeguarding the momentum and integrity of clinical case of premature site closure the CREL should be consulted to discuss site closure options to manage the Principal Investigator and site staff expectations and to enable adequate communications to preserve site relationships and site satisfaction.

The CREL acts as a local escalation point for study level challenges and ensures rapid resolution in collaboration with other parties involved (e.g. supporting other Clinical Operations roles such as SSUL when needed).

At sites of strategic importance the CREL assigned shall focus on building stronger and deeper relationships with all relevant operational site stakeholders beyond the investigators (e.g. pharmacists clinic administration etc.) to engage on above study / transactional site level topics. The CREL proactively assesses improvement opportunities for the site engagement strategy. The CREL actively listens and understands sites needs to better respond to their requests and propose solutions to enhance site experience engaging sites on topics that are of most importance to them. The CREL acts as site champions and as a Clinical Operations Primary Point of Contact (PPOC) to maintain cross-study consistency address cross-study questions and work closely with other internal / CRO roles. The CREL tracks site feedback to identify trends and common challenges and supports solution implementation across all studies identifies lessons learned and best practices working to incorporate them into our clinical trial operations prospectively.

Communication and collaboration with external and internal stakeholders and CROs

Seamless communication and collaboration with external and internal stakeholders and CROs lead to smoother site operations and quicker problem resolution. By working closely with the other relevant internal functions engaging with sites (e.g. Medical Affairs GMCL MSL) other global / local Clinical Operations roles and the CRO team the CREL ensures that sites receive consistent support minimizing disruptions and increasing the chance of successful trial execution to ensure high levels of site satisfaction. The CREL identifies lessons learned and best practices and shares the solution with internal stakeholders where relevant for other sites.

Oversight for global and local assigned studies for ongoing portfolio management The CREL may provide planning oversight and operational delivery of assigned clinical studies in accordance with Roche quality standards all applicable regulations timelines and budget commitments.

Develops and maintains optimal site relationships with investigator sites alliance partners and/or collaborative groups.

Plans and executes country study goals and commitments and ensures compliance to relevant processes.

Highlights deviations and risks in plans to relevant parties develops and implements mitigation strategies as required.

Provides Global Teams with feedback from a country perspective.

Provides study oversight and support to the CRO staff to ensure overall delivery at the country and site level.

Oversees site monitoring performance preparation of Risk Based Monitoring plans and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.

Collaborates in local quality / compliance review internal audits and regulatory inspections ensuring inspection readiness at all times and completion of Corrective and Preventive Actions for allocated studies.

Qualifications

Education

Degree (MD PhD MA / MS BA / BS) in life sciences or equivalent. Postgraduate degree or masters degree will be valued but not required (depending on each countrys requirements).

Experience

Significant experience in the pharmaceutical or related industry.

Experience in end-to-end product development is essential.

Understanding of end-to-end clinical trial processes and strong knowledge of clinical trial regulations and guidelines.

Proven track record in managing site relationships and overseeing complex clinical trials. Fluency in written and spoken English is mandatory.

Fluency in written and spoken language(s) of the host country is mandatory. Ability to travel to meet the demands of the job: travel to sites on an on-going basis to establish and maintain strong working relationships. Frequent International and/or domestic travel may be required.

Skills

Demonstrated customer centric mindset and behaviors building trust and positive and strong sustainable relationships with external and internal stakeholders and CROs. Exceptional communication and interpersonal skills with the ability to build and maintain positive relationships with site personnel and other external and internal stakeholders. Proven influencing and negotiation skills.

Problem-solving: Proactively identify challenges and develop effective solutions by using analytical thinking tools and judgement.

Ability to manage multiple priorities and work in a fast-paced dynamic environment. Team Collaboration: Ability to work within cross-functional teams and foster collaborative relationships.

Strategic Leadership with the ability to demonstrate flexibility and agility working cross-functionally and leading through ambiguity.

Critical thinking and growth mindset.

High ethical standards and professionalism.

Proactive results-driven attitude.

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.