Proclinical is seeking a dedicated ClinicalSupplyChainProjectManager.
The successful candidate will be responsible for defining the Investigational Medicinal Product (IMP) design and the associated supplychain strategy to ensure sufficient supply for clinical trials.
This role involves coordinating with stakeholders to set up and maintain the supplychain plan related to clinical trials.
The role also requires active involvement in the continuous improvement process and knowledge management relating to the development of New Chemical Entities (NCEs) and Life cycle management of commercial products.
Key Responsibilities:
Facilitate a cross-functional team in charge of setting up clinical studies.
Represent the Global ClinicalSupply Management (GCSM) within clinical study team meetings.
Define project scope and objectives ensuring technical feasibility.
Develop comprehensive project plans to ensure on-time supply to patients.
Develop strong collaboration with Global Regulatory Affairs and CMC Regulatory teams.
Evaluate impact of changes to the project scope, schedule, and costs.
Initiate and maintain risk assessment to minimize supplychain potential risks.
Track project performance, analyzing the successful completion of short and long-term goals.
Propose the design of the IMP kits in partnership with packaging team or Contract Development and Manufacturing Organization (CDMO).
Manage the labelling definition and approval.
Define initial needs to support clinical trials with the Forecast Manager.
Manage quality events (deviations, change controls) in line with defined KPIs.
Support continuous improvement projects within the Global ClinicalSupply Management Department and/or wider Pharmaceutical Development.
Requirements:
Pharmacist, engineer or university graduate with a postgraduate degree in health industry.
Experience in project management.
Good communication skills and ability to work in a matrix and global environment.
Strong organizational skills.
Proficiency in French and English.
Experience and knowledge on handling large and complex clinical trials (preferred).
If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.salehproclinical.com Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
ProclinicalStaffing is an equal opportunity employer.
