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Job Details

Clinical Supply Manager - Project Manager

Company: Planet Pharma Staffing Limited
Location: Braine-L'alleud, Belgium
Reference: 12147
Closing Date: 25 Dec 16
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Great opportunity to contribute to a standing organization in clinical supplies management!

Requirements:

Nature & Scope:

-          Project Management of Investigational Medicinal Product (IMP) supply for assigned clinical trials, implementing strategy defined in collaboration with stakeholders, and providing visibility on clinical supply chain throughout trial:

-          Plan, coordinate and communicate clinical supply activities for all applicable clinical trials to optimal quality, time and budget. 

-          Manage the complete IMP supply chain for assigned studies.

-          Scope: All clinical trials (phase 1-4) + Expanded Access Programs with CTS involvement

Essential Responsibilities:

-          Manage the set-up, maintenance, and close-out 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, labeling, 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.

-          Suggest/contribute to/ lead CTS process improvement initiatives

-          Manage deviations, investigations and change controls in the Quality Management System (Trackwise)

-          Lead/Participate in the writing and review of procedure, instructions and forms. Train CTS colleagues on these procedures and instructions.

Priorities:

-          Implementation of project management best practices

-          Partnership with Key Stakeholders, Drive Early/Formal Involvement

-          End-to-End Optimization, Successful Patient Supply

-          Patient Value Creation.

-          Operational excellence: Cycle time Reduction, efficiency increase.

Apply for this job: Clinical Supply Manager - Project Manager

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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