Manager, Clinical Supply Operations in Bernards, NJ at Apex Life Sciences

Date Posted: 10/13/2018

Job Snapshot

Job Description


Manager, Clinical Supply Operations

Please note, this is a contract role with a possibility for extension.

Duties:

  • Participate in study team meeting, align with study details and collaborate in meeting study objective, Provide supporting information to the teams
  • 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.
  • Generate RFPs for Vendor Proposals - Breakdown Protocols into component parts to support the supply strategy and communicate the study needs to obtain vendor based budgeting or internal support
  • Vendor selection to support studies is evaluated according to capability and fit with outsourcing Strategy and selection of contractors is made in agreement with line management. Contracts are negotiated in collaboration with Outsourcing Vendor Management - Proactively review with the Vendor the study status on a regular basis. Review the initial supply needs for start-up, ongoing resupply strategy and amendments and closeout requirements. 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.
  • ICSO supports the generation of the CSO relevant  section of User specifications for IRT and User Acceptance Testing, taking responsibility for the relevant portion of the IRT process covering essentially dispensing and triggers for re-supply and controls to ensure non dispensing of expiring or expired product. The requirements also cover all relevant report functionality.

Requirements:

  • BS in science-related field; MS or PharmD a plus
  • Minimum of 5 years of related experience
  • Experience with project management, clinical supply management, and/or pharmaceutical development required
  • Experience with managing 3rd party contract clinical supply operations
  • Must have global experience
  • Strong knowledge of GMPs & GCPs across multiple therapeutic areas
  • Knowledge of IRT design

#LI-KS1

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




886234