What are the responsibilities and job description for the Senior Clinical Supplies Manager position at catalent?
We are looking to recruit a Senior Clinical Supplies Manager (CSM) to join our team supporting our Clinical Supplies network globally.
The Senior Clinical Supplies Manager (CSM) should demonstrate expertise in performing the activities required to provide leadership and support in the planning, development, and execution of clinical trial supply chain activities and have the ability to drive cross-functional deliverables and manage activities of multiple supply partners and functions (e.g. packaging and distribution, depots, logistics). This role is instrumental in timely planning, accurate forecasting and in managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and the ability to respond rapidly to issues as they arise.
The Role
- Understand and translate clinical study protocol requirements into demand for drug product and ancillary supplies within a clinical study
- Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs
- Create study drug projections and supply plans for clinical trial supply needs throughout life of the study including multiple drug campaigns and appropriate drug strategies
- Work with IRT in creation of system specifications (URS) associated with supply algorithms
- Update clinical supply demand forecasts as new information becomes available (excel and available forecasting tools ).
- Act as the Un-blinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study
- Monitor and oversee Warehouse and Depot drug levels within IRT throughout study.
- Coordinate with the client and packager to forecast, plan and schedule packaging campaigns and driving timeline to the desired deliverable
- Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study
- Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life
The Candidate
- Bachelor's degree in a science, supply chain or related discipline
- Extensive, proven relevant industry experience in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle
- Experience in supply tracking requirements and systems
- Experience in the use of forecasting tools.
- Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
- Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR)
- Strong knowledge in IRT technology as it relates to supply chain management
- Experience of using MS Office programs, with a particular aptitude for MS project and Excel.
Position Benefits
- Annual Salary
- Pension
- Bonus
- Life Assurance
- Bupa Healthcare
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
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Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
