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.
Key Responsibilities:
Identifies contributes to and participates in continuous improvement and change management bringing new perspectives to solve problems.
Maintains a global reach with minimal guidance to support local business needs and ensure role clarity across PDG fostering a culture of collective success and high performance.
Collaborates with study teams Clinical Operations Excellence colleagues and Quality and Compliance experts to optimize processes and ensure strong compliance and quality assurance.
Is accountable for GCP/GVP compliance business process ownership and data integrity taking a balanced risk-based approach and seeking guidance when necessary; may partner with vendors.
Fosters knowledge sharing supports technology adoption for study delivery and promotes new ways of working utilizing data AI and innovative technologies.
You will bring subject matter expertise working cross functionally in one or more of the following areas below:
Quality and Compliance:
Contribute to 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. Supports the maintenance of global and local regulatory compliance (GCP/GVP/IxD/GMP) audits and corrective action management. Promotes data quality and integrity and supports monitoring of interventional trial compliance (AMCO/global)
May be a PDG Business Process Owner
Business Process:
Leads 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:
Implement and support 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.
Enables efficiency and empowered decision-making by ensuring timely access to critical information thereby ensuring the organization remains at the leading edge of clinical trial execution.
Knowledge Management:
Drives the implementation of 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.
Supports the timely adoption and 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.
Where pay transparency applies details are provided based on the primary posting location. For this role the primary location is Shanghai. If you are interested in additional locations where the role may be available we will provide the relevant compensation details later in the hiring process.
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.
Required Experience:
Manager
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.