Contract - Clinical Supply Chain Specialist

Location
San Francisco, CA, United States
Posted
Jun 05, 2021
Ref
1132
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
CONTRACT - CLINICAL SUPPLY CHAIN SPECIALIST

Position Summary:

The Clinical Supply Chain Specialist will perform a variety of tasks in support of the Clinical Supply Chain team to supply clinical trial material for global clinical studies at various stages of development. The Clinical Supply Chain Specialist will be assigned to and work under the direction of a Clinical Supply Chain Manager. While executing the assigned duties, the Clinical Supply Specialist may work with other groups including Quality Assurance, Regulatory Affairs, Manufacturing, and specific outside vendors. Good initiative, communication, problemsolving, and MS Office skills are required for success.

Essential Duties and Responsibilities:

  • Label text - Initiate label text and label proof approval forms and route to required groups for approval within timelines required to provide clinical supplies. Follow up on label translations with Study Managers and provide to the CMO to develop Label Proofs. Maintain label text documentation and reconciliation in well-organized folder structures for accurate and easy retrieval
  • Pre-production documentation- Complete and circulate variable data documents for approval. Conduct part number review and initiate generation process under the direction of the Clinical Supply Chain Manager
  • Clinical Trial Material Request (CTMR) - Route initial CTMRs for approval to required groups and maintain a record of CTMR's for tracking purposes. Update CTMR versions as needed under the direction of the Clinical Supply Chain Manager and route for approval. Also, maintain CTMR documentation in well-organized folder structures for accurate and easy retrieval
  • Production Schedules - Update documents containing packaging/labeling production schedules with relevant information including key dates. At the discretion of the Clinical Supply Chain Manager, responsibilities may be expanded to include generating production schedules, project plans and related documentation
  • Upload final packaging and labeling documents, as necessary, into the eTMF for each study
  • Specific responsibilities will vary based on the incumbent's experience and capabilities and may include other tasks not listed here at the discretion of the assigned Clinical Supply Chain Manager
  • Business Relationships - Effective collaborator and communicator. Interface with other members of GBT's Supply Chain team, cross-functional GBT team members and packaging vendors as required to meet deliverables
  • Procedures - Follow Standard Operating Procedures (SOP's) Contribute to develop and/or update function specific procedures


Qualifications:

  • BS/BA degree
  • Good organizational and communication skills, effective time management skills and able to adhere to timelines
  • Excellent interpersonal skills
  • Customer Service oriented, collaborative and self-starter
  • Proficient in Microsoft Outlook, Word & Excel. MS Project and SmartSheet capabilities a plus
  • Working knowledge of cGXP