Sr Manager, Global Clinical Operations (GCO) - Vendor Management Oversight

  • Cambridge, MA
  • Full-time
  • Work Location: This is a hybrid role that requires part-time work on-site
  • Department: Research & Development
  • Region: US

Job Description

As the Senior Manager, Global Clinical Operations (GCO) - Vendor Management Oversight, you will be a primary strategic point of contact at Biogen for the Vendor Relationship ensuring appropriate oversight is in place and chairing governance meetings on behalf of Biogen. You will utilize KPI data and other performance measures to assess vendor performance and utilize this data to collaborate with functional SMEs, the CRO strategic partner and vendors directly to identify and implement process improvements to drive value and efficiency in the service delivery of the Vendor.

The Global Clinical Operations (GCO) Vendor Management team supports GCO to provide oversight of the end-to-end vendor management process for GCO Vendors and is responsible for driving process improvements and governance of key GCO Vendors. The Vendor Manager is a core member of the GCO Vendor Management team who has primary accountability within the team for supporting oversight of Vendor contracting and performance, assuming the role of Vendor Ambassador for some key GCO Vendors, as assuring efficient onboarding of Vendor activities to support rapid Study Start Up. 

What You’ll Do: 

  • Oversee the process of functional contracting, assessing process and implementing updates to model in order to support expedient contract delivery, which includes purchase order creation/submission/documentation, contract drafting, coordination with the business on scope and/or verifying requirements of the business, negotiating with the external party on legal language, ensuring adherence to master pricing/fair market value/Biogen’s pricing standards, contract execution and contract filing in Biogen’s contract repository DETERMINE.  
  • Ensures Timely escalation of issues as required for efficient resolution.
  • Provide oversight of third-party vendor activities & support to study management teams and other GCO functions to oversee operational end-to-end vendor escalation and mitigation of key vendor issues/challenges. 
  • Support department oversight strategies which include status of vendor deliverables and third-party vendor metrics data.
  • Support R&D processes as they relate to Vendor Operational qualification/documentation, Vendor Performance Management and support of Vendor audit and inspection activities.  
  • Collaborate on department processes and templates.
  • Handle projects and initiatives as requested by Biogen, including those as they relate to vendor governance activities. 
  • Serve as Vendor Ambassador for certain vendors, ensuring oversight and governance plans are in place and vendor specific processes are in place where appropriate at Biogen and within CRO Strategic Partners.
     

Qualifications

Required Skills 

  • Bachelor’s degree required; Masters preferred
  • 5+ years experience in the biotech, medical device, and/or pharmaceutical industry while working with CROs and clinical vendors 
  • Demonstrated interaction, creativity, and problem-solving skills with the management of clinical service providers
  • Ability to manage multiple programs and processes simultaneously and working effectively in cross-functional and global teams
  • Dedication to quality in all work tasks and deliverables 
  • Risk management, mitigation and problem-solving in an ambiguous, fast paced environment 
  • Proven negotiation and organizational skills 

Preferred Skills 

  • Experience working in a global/cross cultural setting
  • Strong understanding of GCP, GLP and financial compliance 

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 

All your information will be kept confidential according to EEO guidelines.

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