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Clinical Supply Manager
Eingestellt von Aerotek
Gesuchte Skills: Design
Projektbeschreibung
MAIN RESPONSIBILITIES:
- Manage the set-up, maintenance, return/destruction and archiving of assigned multi-national Phase 1-4 trials (through delegation to Clinical Supply Associates when deemed appropriate):
- Drive strong partnership with stakeholders, in particular Clinical team. Participate in Joint Clinical Study Teams as a liaison for CTS. Educate and influence as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain.
- With guidance of Clinical Supply Program Manager, define an optimal IMP supply strategy to ensure adequate and sufficient forecasting of drug product, comparators, and final IMP.
- Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical sites.
- Set-up and write Core Label Text documents and coordinate the Country Label Text translation and regulatory approval process.
- Achieve planned milestones regarding clinical supply related trial set-up activities including packaging, labelling, Interactive Response Technology (IRT) requirements/specification development, distribution, and return/destruction.
- Contribute to IRT specification development by defining the requirements for IMP/inventory management. Participate in IRT User Acceptance Testing.
- Lead/Contribute to Operational Kick-Off Meetings with CTS functions, Distribution and QA, to share study information, collect input on packaging design and timelines, and agree on the trial project plan.
- Monitor IMP inventory quantities and expiry dates.
- Present IMP information at Investigator Meetings.
- Plan and monitor CTS trial budget, and communicate any required adjustments to Clinical team and Clinical Supply Program Managers.
- Ensure Clinical Supply Program Manager visibility on clinical supply chain for assigned trials, proactively identifying risks and escalating issues.
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.
- Manage the set-up, maintenance, return/destruction and archiving of assigned multi-national Phase 1-4 trials (through delegation to Clinical Supply Associates when deemed appropriate):
- Drive strong partnership with stakeholders, in particular Clinical team. Participate in Joint Clinical Study Teams as a liaison for CTS. Educate and influence as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain.
- With guidance of Clinical Supply Program Manager, define an optimal IMP supply strategy to ensure adequate and sufficient forecasting of drug product, comparators, and final IMP.
- Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical sites.
- Set-up and write Core Label Text documents and coordinate the Country Label Text translation and regulatory approval process.
- Achieve planned milestones regarding clinical supply related trial set-up activities including packaging, labelling, Interactive Response Technology (IRT) requirements/specification development, distribution, and return/destruction.
- Contribute to IRT specification development by defining the requirements for IMP/inventory management. Participate in IRT User Acceptance Testing.
- Lead/Contribute to Operational Kick-Off Meetings with CTS functions, Distribution and QA, to share study information, collect input on packaging design and timelines, and agree on the trial project plan.
- Monitor IMP inventory quantities and expiry dates.
- Present IMP information at Investigator Meetings.
- Plan and monitor CTS trial budget, and communicate any required adjustments to Clinical team and Clinical Supply Program Managers.
- Ensure Clinical Supply Program Manager visibility on clinical supply chain for assigned trials, proactively identifying risks and escalating issues.
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design