Global Outsourcing Specialist Asia/Pacific

Major Responsibilities

• Work with the respective Global Sourcing Leads within BHC R&D Procurement to ensure the functional outsourcing requirements are met during vendor selection.
• Ensure the functions resourcing requirements are fulfilled within the assigned projects by supporting the responsible outsourcing person (eg the Study Manager, Global Clinical Leader, or Functional Leader) through the sourcing process. This level of support will vary according to the outsourcing experience of the individual or team.
• Support the responsible outsourcing person determine the outsourcing scope and ensure these are appropriately completed in the Request For Proposal and scope is finalised following Kick-off Meeting.
• Support the responsible outsourcing person throughout study conduct to determine changes in scope, if necessary.
• Ensure that approval for such changes in scope is obtained from the respective BU Head via the Global Clinical Leader before changes are implemented.
• Guide the responsible outsourcing person in managing the overall relationship with the vendor and in the resolution of issues related to CRO performance in cooperation with BHC R&D Corporate Procurement.
• Support the responsible outsourcing person to ensure the costs are managed effectively (monthly estimates, liability, risks and opportunities, payments, invoice review vs milestones).
• Establish and maintain an effective relationship with the Study Management, the Clinical Development and the Medical Affairs organization, the Study and Clinical Teams, and with the respective Global Sourcing Leads in Procurement.
• Establish a framework to ensure only required SOPs are sent to the suppliers, and these are tracked.
• Ensure the CROs and other suppliers understand the business requirements, through appropriate training.
• Ensure the Task Definition Documents, detailing the business requirements, are appropriate.
• Ensure a knowledge of the outsourced activities/studies, including potential changes in scope and cost implications.
• Ensure lessons learned are communicated across outsourcing activities, to ensure functional best practice.

Requirement

• The incumbent must have a Bachelor’s degree and 10 years of relevant clinical development experience with a pharmaceutical company, or a Master’s Degree and 8 years of relevant clinical development experience with a pharmaceutical company. The incumbent must have previous experience as a Study Manager and should have a minimum of 2 years direct management experience.
• The incumbent is responsible for overseeing the management of outsourced Phase II-IV complex and global clinical trials. He/she therefore needs comprehensive knowledge of the drug development process and the regulatory framework for conducting clinical trials. The incumbent must have experience in the management of outsourced study activities and in the management of cooperations with CROs, as well as experience in budget and resource planning.  The position also requires awareness and understanding of cultural differences as well as regional operational differences.
• The incumbent needs thorough knowledge of oral and written English, effective written and verbal communication skills, with the ability to take a clear position and communicate accordingly (e.g. when specifying BSP’s expectations towards a CRO). Excellent negotiation and conflict resolution skills are required, as well as training skills and the ability to provide guidance to others. In addition, the incumbent requires excellent follow through and the ability to represent BSP’s interests in high-level groups like Governance bodies between BSP and CROs.