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Clinical Supply Study Manager - F/M

Company: Sanofi
Location: Bridgewater
Posted on: June 25, 2022

Job Description:

JOB PURPOSE The Clinical Supply Study Manager (CSSM) is accountable for the clinical supply operational management in a clinical trial. The CSSM is responsible to ensure for each study he/she has under supervision that supplies are delivered on time, within budget and in compliance with GXP's, SOPs, and standards. The CSSM is responsible of the coordination of CSCO team in order to ensure the execution of the clinical supply study activities.The CSSM collaborate with CS Optimization Specialist to define the most optimized settings. The CSSM is responsible to setup the best strategy for the study setting and communicate to the study team.He/she oversees a Clinical Supply Production Plan for a study and ensure progress according to study timelines. He/she leads the Operational Supply Meetings. He/she should ensure study activities are aligned with the projections. If not, he/she has to revise the strategy to optimize the clinical supply chain and mitigate any risks.He /she is the key contact to the Global Study Manager in charge of the study and she/he is part of the Core Study team, as the leader and expert for clinical supply activities.He/she contributes to the review of the study documentation (Protocol, Monitoring Plan, Pharmacy manual/Instructions for Use, and CRA presentations) especially for the IMP/NIMP impacts and discusses the design of the study for streamlining the use of supply in the study. He/she is also responsible for the preparation of study related materials, documents in order to support the local team for the site initiation.He/she is also responsible to coordinate the discussion for the devices sourcing strategy He/she reports to the Therapeutic Area Group Head.KEY RESPONSIBILITIESCoordinates overall CSCO operations of the entire clinical study including study planning, budget, resource management, regulatory practices, policy adherence and contract research organization management (when applicable)Compile needed information for IMP/NIMP/medical devices to get best strategy settings from CS Optimization SpecialistsEnsure 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 requirementsGenerate/Contribute to treatment identification list based on CS Optimization Specialist recommendationsCollaborate with the CS Optimization Specialist to define the best and optimized study supply strategy (Production Plan)Strongly Recommend the final strategy to the study teamMonitor adherence to approve master study plans for packaging and distributionCoordinate the distribution logistics for assigned studiesDevelop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IMP/nIMP (and Medical Devices) at depots and investigational sitesEnsure adequate stock at depot and site levelsSupport relabeling activity at local and depot levelsEnsure the IMP/NIMP needs with Clinical current data are accurate and update IMP/NIMP needs, master study schedule for packaging and distribution when neededPerform and Coordinate transfers of supplies between sites and/or depotsGenerate and/or review shipment requests for accuracy & completeness prior to issuanceMonitor the IMP/NIMP/Medical Devices flow throughout the course of the studyEnsure the final drug reconciliation is completed on timeDefine the study budget for CSCO operations (Packaging, Distribution, IRT, Marketed products,), and monitor the consumption all along the study. Alert, risk assessment and mitigation plan to provide in order to ensure no budget issuePropose creative/innovative solutions to optimize the clinical supply chainAttend internal CS project team meetingsDevelop study related documents and IMP preparation directions for the clinical sitesActively Contributes to the Study ID card and pressure testsReview, comments and contributes on IMP/NIMP sections of the study protocolContribute and review the Monitoring Plan, Pharmacy manual/Instructions for Use, and CRA/RTM/IPM presentationsIRT set-up and follow-upOversee the IRT set-up by IRT contributorDevelop IRT RFP, specifications and perform UAT, prior to IRT Go LiveMonitor and share IRT study budget consumptionProblem solvingPropose actions and mitigations plans for decision makingAnticipate risksCoordinate the mitigation plansOrganize CSCO study meetingsOrganize and Conduct Operational Supply Meeting including operational planning (retroplanning), risk management discussions all along the study lifeOrganize and lead TCs with local teams (IPM, RTM) to present IMP/NIMP/Medical Devices study managementParticipate in investigator meetingsOrganize and lead meetings/TCs with IRT vendors (for IRT set-up and amendment)Collect, synthesize and report study informationCompile, analyze and provide information for monthly CSCO study reports (monitor study budget consumption, CSCO study variance, milestones/timelines adherences, changes, risks, optimization)Work with the Study Team to ensure that forecasting projections and manufacturing schedules are in line with trial progressLead transversally studies in CSCO, able to influence upstream decisions and strategy, sharing CSCO cost & risk to support decision making.MAIN INTERACTIONSInteract withDemand & Supply LeaderCSO Project LeaderEntire Study team memberAll internal functions in CSCO (e.g. CS POL and/o CSSL, CS Optimization Specialist)IPMCSCO Industrial Development HeadQuality Project Focus PointCS Packaging ManagersCS Vendor Management HeadGlobal Study Manager (leading the study team)All decision-making linked to management of studies in CSCO, Resolves CSCO operational issues that could affect IMP delivery timelines or quality in conjunction with CS study leaders, the CS Project Operational Leader, Therapeutic Area Group Head and other CSCO functions upon need. Proposes options to the study team that optimizes the value of the study(ies) while taking into account other functions constraints.PROFILEEducation and ExperienceBachelor of Science degree (BS) in Health Science or related discipline2 years' experience in pharmaceutical business requiredPrevious experience in Clinical developmentKnowledge and skills requiredLeadershipAble to lead the WW supply team (into CSCO)Able to lead transversal activitiesAble to challenge / decisions/ status-quo with teams including study teamAble to promote the team spirit and the Collaborative mindsetOversight and coordinationGood Project Management skillsGood organizational skills and multi-tasking skills (Effective time management skills)Sense of urgency, prioritize workload with dynamic, culturally diverse organizationAble to work autonomous and providing appropriate reporting to study team and CS Study Leader or CS POLAble to oversee all other supply activities (CSPM, external vendor etc.)CommunicationGood communication skills (written and oral)Good negotiation skills, strong problem-solving skillsDecision Making & problem solvingAble to identify and anticipate riskAble to provide mitigation plan, actions plan for decision makingAble to solve problem and make decisions when neededKnowledge and skills desired but not essentialGood Knowledge of clinical developmentGood knowledge of the Clinical Supply Chain process, GMP, GDP and other regulatory requirements as they pertain to investigational productsThorough understanding of GMP & GDP (IP production and distribution)Thorough understanding of IRT systems, CMC Product FlowAt Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.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.GD-SALI-SAPDNAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.PDN-95b00e89-cb9d-47fa-be8c-e5d7b376685b

Keywords: Sanofi, Trenton , Clinical Supply Study Manager - F/M, Executive , Bridgewater, New Jersey

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