Technical Operations Manager (Clinical Supply)

Location: Cambridge, Massachusetts, United States
Salary: negotiable
Job Type: Permanent
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Technical Operations Manager- Clinical Supply Chain

Our client is seeking a highly motivated individual to join as a Technical Operations Manager - Clinical Supply Chain.

The successful candidate will be responsible for developing and managing the clinical supply plan for global clinical trials (all phases). This individual must have significant experience with clinical finished goods supply and production requirements, distribution activities, and labeling operations. This individual will work with external vendors and internal stakeholders to accomplish program objectives.

Responsibilities:

  • Ownership of clinical supply plan for global clinical trials (all phases)
  • Ownership of manufacturing/distribution relationship with external clinical suppliers
  • Supply management and setup/oversight of Interactive Response Technology (IRT)
  • Drive the label development internally and externally
  • Review and approval of documentation associated with clinical finished goods
  • Cross functional collaboration with internal team members, including but not limited to, quality, clinical operations, CMC, supply chain, and program management
  • Develop advanced planning tools in Excel (including distribution/manufacturing, expiry of IMP, timing)
  • Create monthly dashboard for clinical supply
  • Well versed in requirement for international shipping requirement for IMP (IoR, customs, providers of these services for clinical trials)

Qualifications:

  • Bachelor's degree in the Life Sciences, Supply Chain Management, Industrial Engineering, or a related field is required. Advanced degree is preferred.
  • Minimum of 5 years of experience in clinical supply chain planning/distribution in a clinical research environment
  • Experience with supply planning and manufacturing/distribution operations for global clinical trials is required
  • Advanced MS Excel skills specific to planning global clinical trial supply
  • Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies
  • Demonstrated ability to work independently and with cross-functional teams
  • Highly organized, detail focused with strong project management skills
  • Ability to multi-task and work in a fast paced environment

If you or a Clinical Supply Chain Manager you know feel this could be an opportunity you would like to explore please send me your most up to date resume at c.hesler (at sign) Realstaffing.com to discuss the role in further detail.

Sthree US is acting as an Employment Agency in relation to this vacancy.

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