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Clinical Supply Operations Manager

Title: Clinical Supply Operations Manager

Duration: 6 Months with extensions

Location: Basking Ridge, NJ

Our client in Basking Ridge, NJ is seeking a Clinical Supply Operations Manager to join their team on a long term contract with possible extensions.

Responsibilities include but is not limited to:

  • Participate in study team meeting, align with study details and collaborate in meeting study objective,
  • Provide supporting information to the teams, in particular RA, RACMC, Clinical ops, and GPMs.
  • Create drug supply forecast for packaging and labelling operations.
  • On-going monitoring of recruitment, drop-out rates and actual supply needs, critical to managing the study needs.
  • Ensure continuous re-assessment of Project needs as recruitment and the study progresses
  • Sourcing of comparators and matching placebo as required on a Project by Project basis.
  • Obtaining cross functional sign off on the labels.
  • Ability to provide budget management for Projects
  • Generate RFPs for Vendor Proposals
  • Address budgets and invoicing considerations with the vendor along with the study management details and capture any impacts.
  • Support of regulatory filings including IND submission information, regulatory audits and information to support regulatory audits.
  • Provide regular updates to the TMF as per departmental and corporate requirements that comply with all regulatory requirements.

Skills:

  • Minimum 5 years of related experience
  • Experience in Project Management, Clinical Supply Management, and/or Pharmaceutical Development required
  • Experience and skill in the processes for assimilation and destruction or returned drug supply as well as experience managing third-party contract clinical supply operations required Global experience required (member of a team)
  • Good knowledge of cGMPs and GCPs across multiple therapeutic areas and possesses general knowledge of blinding approaches and technologies to support various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)
  • Experienced to manage study needs and possesses the skills and ability to potentially support large phase III Programs.
  • Such characteristics include the ability to evaluate, at times, limited information, to create packaging designs and accurate drug supply forecast.
  • Experienced in managing third-party contract clinical supply operations.
  • Employee should have comprehensive knowledge of IRT design for control of drug dispensing and inventory management.
  • Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations at a Global level, regulations for IMP QP requirements.

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