CRO Oversight Manager

Shanghai, China

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The Position

Responsibilities/Duties

Develop, manage and maintain relationships with CROs in China at the operational level (e.g. regular communications, issue management, organization of visits/meetings)

Perform regular landscaping of the Chinese CRO-market

Provide oversight and management of assigned vendors used by PS for outsourcing of work including scope and volume of outsourced activities, overall spending, etc.

Ensure documentation and tracking of issues for communication, possible follow-up and timely resolution

Ensure CRO governance in PS by supporting the coordination, planning, execution, reporting and following up on action items of CRO governance meetings (e.g. EC meetings; Operations Meetings) as well as CRO inspections and visits (both at CRO and Roche sites)

Ensure that appropriate compliance /GLP or GCP is maintained at Roche preferred CRO’s Ensure that HA-related questions or issues are adequately addressed

Build a strong interface to

  • Global SOOE-organization
  • Local Bioanalytical –and Biomarker groups
  • Local –and global procurement organization
  • Local Roche Shanghai-organization (eg. PD, Biosample Operations, Oncology)

Support the development, implementation and regularly revision of optimized/harmonized operational practices/processes incl. the related outsourcing process documentation (e.g. guidelines, SOPs, white papers)

Ensure compliance with pRED and procurement outsourcing policies and procedures

Support line management in the establishment of new outsourcing strategies/models and the incorporation of strategic sourcing tools that drive continuous improvement, optimize quality of the sourcing process and generate measurable savings for PS/pRED

Establish strong interfaces at RICS with Procurement, Finance, pREDi to ensure CRO oversight for selected CROs

Qualification (Training/experiences)

  • University education in Science (Human or Veterinary Medicine, Chemistry or Biology) or Business or Data management at a Masters or PhD degree level
  • At least 5 years of experience in the pharmaceutical industry
  • Good understanding of fields of outsourcing, procurement and business management
  • Good knowledge of local and global GxP regulations with focus on GCP
  • Good knowledge in business support solutions (e.g. databases, Excel, PowerPoint, Spotfire)
  • Demonstrated skills in communication, collaboration and stakeholder management
  • Basic knowledge about Chinese HA-regulations
  • Strong negotiation and influencing skills
  • Excellent team player

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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