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Manager, Clinical Supply Operations II

Basking Ridge, NJ 07920

Posted: 02/13/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 546351-1 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 50-100/hr **salary will be commensurate with experience 

Job Summary:
  • 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.
  • 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 with the most favorable terms for DS 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.

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. 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.

Education:
  • BS in Pharmacy or related field—MS or PharmD a plus


**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.