Job Title: Clinical Supply Operations Manager
Location: Basking Ridge NJ
Duration: 4+ Months
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.
Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential solutions to provide patient friendly designs and support of simplified site dispensing approaches.
Create drug supply forecast for packaging and labeling operations. Support patient study needs that consider enrollment rates, country logistics for shipping and importation, drug expiry, inventory re-supply strategy and the appropriate level of inventory per region.
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.
Drive label generation and approvals, including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels.
ability to provide budget management for Projects - initial budgets are prepared against available information and a set of assumptions and become more stringent as the study start approaches. Spend against PO's are monitored and extensions justified. Costs saving strategies are employed when appropriate. Invoices are reviewed and approved against targeted budget plans.
Experience in clinical supply management.
Experience in Project Management, Clinical Supply Management, and/or Pharmaceutical Development required.
Experience 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).
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. Support the CSO strategy on specific Programs and Projects to support corporate goals and objectives.
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.
A Bachelors degree in Pharmacy or related field is required.
Please feel free to call at