Go to search Go to main content

A Range of Possibilities

Clinical Supply Study Manager

date posted 06/23/2022
contract type Full time
job id R2635382
location Bridgewater, New Jersey

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 RESPONSIBILITIES

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

Problem solving

  • Propose actions and mitigations plans for decision making

  • Anticipate risks

  • Coordinate the mitigation plans

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.

MAIN INTERACTIONS

Interact with

  • 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)

  • IPM

  • 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.

PROFILE

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

  • Leadership

    • 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

  • Oversight and coordination

    • Good Project Management skills

    • Good organizational skills and multi-tasking skills (Effective time management skills)

    • Sense of urgency, prioritize workload with dynamic, culturally diverse organization

    • Able to work autonomous and providing appropriate reporting to study team and CS Study Leader or CS POL

    • Able to oversee all other supply activities (CSPM, external vendor etc.)

  • Communication

    • Good communication skills (written and oral)

    • Good negotiation skills, strong problem-solving skills

  • Decision Making & problem solving

    • Able to identify and anticipate risk

    • Able to provide mitigation plan, actions plan for decision making

    • Able to solve problem and make decisions when needed

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

At 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-SA 

#LI-SA 

PDN

At 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.

Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

Continue

Here's who you know at Sanofi!

Reach out to find out more about our company, this opportunity and request a referral.

Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

Continue