Clinical Supply Chain Project Manager

Il y a 9 mois

Dreux, France IPSEN Temps plein

**Title**:
Clinical supply chain Project Manager

**Company**:
Ipsen PharmSciences SAS

In respect to Good Manufacturing Practices and as part of the Global Clinical Supply Management department (GCSM), the clinical supply chain project manager
- defines the IMP design and the associated supply chain strategy to ensure sufficient supply for clinical trials
- coordinates with his / her stakeholders the set up and the maintenance of the supply chain plan related to Ipsen clinical trials

This entails to be strongly involved in the continuous improvement process and knowledge management relating to the development of NCEs and Life cycle management of commercial products within the DPD department.

**Project management responsibilities**
- Facilitate a cross functional **CMC sub team**, in charge of the set-up of clinical studies and which includes operational quality assurance, clinical packaging and distribution for internal projects and CDMO management for outsourced projects
- Represent **GCSM** within clinical study team meetings and ensure seamless alignment with clinical trials milestones (timelines, study design assumptions, recruitments assumptions etc)
- Define with its sub team the project scope and objectives while ensuring technical feasibility
- Develop with its sub team comprehensive project plans to ensure on time supply to patients and avoid IMPs stock out
- Validate the strategy with the **Clinical Supply Chain Therapeutic Area Lead**:

- Develop strong collaboration with **Global Regulatory Affairs** and **CMC Regulatory** teams to ensure alignment of regulatory strategy (submission filing, product references to be used)
- Evaluate impact of changes to the project scope, project schedule, and project costs
- Facilitate the sub team to solve complex challenges and provide mitigation plans in a timely manner to meet the business needs
- Escalate challenges / issues to management when needed
- Measure performance using appropriate project management tools and techniques
- Initiate and maintain risk assessment to minimize supply chain potential risks
- Track project performance, specifically to analyze the successful completion of short and long-term key goals (OTIF, forecasts KPIs, RFT etc)
- Present the results and progress of projects under his/her responsibility at internal / external meetings
- As per delegation from the Supply Chain TA Lead:

- Can represent **GCSM** in CMC project meetings and ensure adequate alignment with Asset Teams objectives (timelines, priorities, need to initiate / review forecasts, communication escalation, anticipate risks and provide mitigation)
- Can represent **GCSM** within **Clinical Operations** strategic meetings and ensure seamless alignment with clinical development programs (overall plan including all studies of the program, study design assumptions etc)

**IMP design and clinical supply chain definition responsibilities**
- Propose the design of the IMP kits in partnership with packaging team or CDMO
- Manage the labelling definition and approval
- Create and maintain comprehensive project documentation (IMP Design and Supply / Handling Manual / Supply Chain Flow Diagram, leaflets)
- Review **Clinical Operations** documentation (CRO scope of work for example)
- Define with the **Forecast Manager **the initial needs to support clinical trials
- Ensure all studies forecasts are revisited on a regular basis with the support of the** Forecast Manager **when needed:

- Organize review meetings with relevant cross functional departments
- Monitor closely the evolution of validated clinical study forecasts and share them with the CMC sub team
- Anticipate and assess impacts on changes on its clinical studies (addition of new countries, sites, number of patients, changes in protocols, etc). Challenge Clinical Project Managers when relevant and consolidate the new / updated forecasts in the appropriate systems.
- Report on the progress of studies and validate milestones
- Perform his / her mission according to (i) the up-to-date internal and external regulatory guidance and process, (ii) and harmonized ways of working / processes as defined by the** Portfolio Management and Processes Team**:

- Manage quality events (deviations, change controls) in line with defined KPIs,

**Continuous improvement responsibilities**
- Support the Process and Compliance Project Manager while defining and / or adjusting GCSM processes / ways of working and providing effective as well as continuous feedback.
- Organize and actively participate in lessons learnt exercises when needed.
- Contribute to continuous improvement projects within the Global Clinical Supply Management Department and/or wider Pharmaceutical Development.
- Be a promoter of continuous improvement processes and to guarantee the method.

**QEEHS Responsibilities responsibilities**
- Respect the Good Practices applicable (BPF, BPD,), the rules of Energy Environment Health and Safety through the procedures applicab

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