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.
Coordinates 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 Specialists
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
Generate/Contribute to treatment identification list based on CS Optimization Specialist recommendations
Collaborate with the CS Optimization Specialist to define the best and optimized study supply strategy (Production Plan)
Strongly Recommend the final strategy to the study team
Monitor adherence to approve master study plans for packaging and distribution
Coordinate the distribution logistics for assigned studies
Develop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IMP/nIMP (and Medical Devices) at depots and investigational sites
Ensure adequate stock at depot and site levels
Support relabeling activity at local and depot levels
Ensure the IMP/NIMP needs with Clinical current data are accurate and update IMP/NIMP needs, master study schedule for packaging and distribution when needed
Perform and Coordinate transfers of supplies between sites and/or depots
Generate and/or review shipment requests for accuracy & completeness prior to issuance
Monitor the IMP/NIMP/Medical Devices flow throughout the course of the study
Ensure the final drug reconciliation is completed on time
Define 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 issue
Propose creative/innovative solutions to optimize the clinical supply chain
Attend internal CS project team meetings
Develop study related documents and IMP preparation directions for the clinical sites
Actively Contributes to the Study ID card and pressure tests
Review, comments and contributes on IMP/NIMP sections of the study protocol
Contribute and review the Monitoring Plan, Pharmacy manual/Instructions for Use, and CRA/RTM/IPM presentations
IRT set-up and follow-up
Oversee the IRT set-up by IRT contributor
Develop IRT RFP, specifications and perform UAT, prior to IRT Go Live
Monitor and share IRT study budget consumption
Organize CSCO study meetings
Organize and Conduct Operational Supply Meeting including operational planning (retroplanning), risk management discussions all along the study life
Organize and lead TCs with local teams (IPM, RTM) to present IMP/NIMP/Medical Devices study management
Participate in investigator meetings
Organize and lead meetings/TCs with IRT vendors (for IRT set-up and amendment)
Collect, synthesize and report study information
Compile, 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 progress
Lead transversally studies in CSCO, able to influence upstream decisions and strategy, sharing CSCO cost & risk to support decision making.
Demand & Supply Leader
CSO Project Leader
Entire Study team member
All internal functions in CSCO (e.g. CS POL and/o CSSL, CS Optimization Specialist)
CSCO Industrial Development Head
Quality Project Focus Point
CS Packaging Managers
CS Vendor Management Head
Global 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.
Education and Experience
Bachelor of Science degree (BS) in Health Science or related discipline
2+ years’ experience in pharmaceutical business required
Previous experience in Clinical development
Knowledge and skills required
Able to lead the WW supply team (into CSCO)
Able to lead transversal activities
Able to challenge / decisions/ status-quo with teams including study team
Able to promote the team spirit and the Collaborative mindset
Knowledge and skills desired but not essential
Good Knowledge of clinical development
Good knowledge of the Clinical Supply Chain process, GMP, GDP and other regulatory requirements as they pertain to investigational products
Thorough understanding of GMP & GDP (IP production and distribution)
Thorough understanding of IRT systems, CMC Product Flow
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