Sr Specialist Trial Supply Operations
Waltham, Massachusetts, Framingham, Massachusetts
This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.
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As the Trial Supply Operations Manager (TSOM), the candidate will interpret the clinical study protocol and determine study IMP / NIMP / ancillary needs. The TSOM will then coordinate the procurement, manufacture, packaging, and labeling of the supplies for both the initial campaign and any resupplies that are needed. Furthermore, the TSOM will manage the distribution logistics for assigned projects throughout the planning, execution, and closeout of Phase I - IV clinical studies to ensure the objectives of the studies are met.
- Forecasting IMP/NIMP/ancillary needs based on protocol design.
- Manage the distribution logistics for assigned projects.
- Develop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IP at depots and investigational sites.
- Develop IRT specifications and perform UAT, prior to IRT Go Live
- Ensure all critical parameters are considered for every distribution strategy; IRT specifications (e.g. initial or resupply quantities); any QP release, study, expiry, customs, import/export, brokerage or country-specific requirements.
- Work with relevant departments to create master labels for each study.
- Ensure adequate stock at depot and site levels.
- Support relabeling activity at local and depot levels.
- Support transfers of supplies between sites and/or depots.
- Generate and/or review shipment requests for accuracy & completeness prior to issuance.
- Ensure accuracy of IP receipt for all shipments and availability in IRT for applicable studies.
- Ensure the final drug reconciliation is completed.
- Provide adequate communication and documentation relevant to the clinical study plan and the movement of all investigational products.
- Contribute to the budgeting and forecasting for all clinical studies.
- Offer creative solutions/proposals to optimize the clinical supply chain.
- Attend various project team meetings.
- Conduct Operational Supply Meeting.
- Work with Clinical Trial Team to ensure that forecasting projections and manufacturing schedules are in line with trial progress.
Bachelor of Science degree (BS) in Health Science or related discipline.
5+ years’ experience in pharmaceutical business required.
The individual must be well versed in all aspects of the clinical supply chain process, GMP, GDP, and other regulatory requirements as they pertain to investigational products.
Excellent knowledge of business units, scientific core platforms, and interfaces.
Clinical study protocols and IP related activities with particular emphasis on manufacturing/packaging, global distribution, and strategy.
Thorough understanding of GMP & GDP (IP production and distribution).
Thorough understanding of IRT systems.
Good understanding of CMC and clinical study conduct activities
Excellent oral and written communication skills high attention to detail.
Excellent negotiation skills, strong problem-solving skills.
Excellent ability to multitask and prioritize workload within a dynamic, culturally diverse organization; effective time management skills.
Exercises calm, sound constructive judgment during highly demanding situations. Ability to organize and lead meetings.
Experience with MS Office Suite (Excel, Word, PowerPoint) required.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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