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.
- 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.