Country Clinical Operations Excellence Leader (cCOE)

Job description

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 PositionKey Responsibilities ● Develop the strategy and implementation plan of CoE initiatives that support PDG's business objectives. ● Oversee the execution and governance of initiatives within global PDG Clinical Operations and with external stakeholders. ● Collaborate with various stakeholders across the enterprise internally and externally such as Study Teams, PDQ, Countries, pRED, gRED etc., to ensure strategic alignment and drive innovation. ● Stay ahead of external learning trends, technologies, and best practices to enhance learning and knowledge management programs and maintain PDG's competitive edge. ● Impact Measurement: Communicate the outcomes of CoE initiatives, such as improved operational efficiency, enhanced decision-making, increased employee engagement, and accelerated innovation. If you are a People Leader (People Manager) in addition to the expectations outlined in this document you will also: ● Provide coaching, support and leadership, as part of the Roche Leadership Framework, to a group of approx. 5-8 direct reports. By exemplifying our Roche values, Leadership commitments and modeling our Roche Operating Principles, you will ensure we achieve our ambitions for our people and patients. ● Conduct a regular year-round assessment of performance, contributions, and impact and provide feedback, coaching, and performance management. ● Lead by example in demonstrating and championing inclusive behaviours in your team, PDG, PD, and the Roche Enterprise. Provide opportunities for growth and development for all team members and address any barriers that may exist. ● People management-related administration (e.g. Workday People & Culture Management system tasks) and contact for employment-related matters. You will lead in a cross functional environment in multiple of the following areas below: Quality and Compliance: ● Leads teams in the creation, improvement and implementation of enhanced global and local processes, policies, and training programs to drive efficiency, standardization, and a strong compliance culture both internally and with our CRO partners/vendors. Ensures maintenance of global and local regulatory compliance (GCP/GVP/IxD/GMP), oversees audit support and corrective action management, safeguards data quality and integrity, leads the development and monitoring of interventional trial compliance (AMCO/global), and acts as a key liaison with regulatory authorities. ● May be a Global Process Owner and or Business Process Owner Business Process: ● Drives the implementation and management of defined clinical operations business processes, ensuring adherence to standards and procedures. Monitors process performance, identifies areas for improvement, and collaborates with stakeholders including CRO partners to implement necessary changes. Learning Management: ● Architect and lead a forward-thinking learning management strategy for Clinical Operations, encompassing both internal and CRO partner training oversight, focused on building future capabilities through innovative learning solutions. ● Drives efficiency and empowers decision-making by ensuring timely access to critical information, thereby ensuring the organization remains at the leading edge of clinical trial execution. Knowledge Management: ● Architects and drives a strategic Knowledge Management framework, deliberately integrating advancements in AI to fuel innovation, operational efficiency, and ensure real-time access to critical information for data-driven decision-making, maintaining Clinical Operations as a leader in these fields. ● Orchestrates the timely adoption and full embedding of cutting-edge AI technologies and knowledge management tools, strategically leveraging data to optimize operational efficiency, enhance outcomes, and establish Clinical Operations as an influential innovator in knowledge management and AI application. Global Expert Clinical Operations Excellence: ● Leads the development and implementation of program-wide IxRS and eCOA strategies and standards in collaboration with program leadership. This involves overseeing process management, ensuring compliance,monitoring performance, and streamlining vendor decisions and oversight. Country Clinical Operations Excellence: ● Responsible for local and regional clinical operations excellence, encompassing vendor oversight, compliance strategies/oversight for interventional trials, and change management, all while ensuring alignment with global CoE and regulatory standards. Act as a primary liaison between various stakeholders, including CRO partners, regulatory authorities, and internal teams (ex medical compliance), and contributes to strategic planning and continuous improvement initiatives, including potentially country leadership and people management. Who we areA 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.