Clinical Supply Study Manager - F/M
Company: Sanofi
Location: Bridgewater
Posted on: June 25, 2022
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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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