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Job Title: Clinical Supplies Planning Manager
Job Location: NJ: Kenilworth
Pay Rate: Open
Job Length: full time
Start Date: 2008-08-29

Company Name: Allegis Group
Contact: Recruiter
Phone: email only please
Fax: email only please

Description: A leading pharmaceutical company is PROACTIVELY seeking qualified candidates for a Global Clinical Supplies Project Manager position. The focus of this position is on Clinical Supplies Planning Management. This is a proactive job listing for a skill set that will open up in the future. SUMMARY: - Support global clinical material production activities by independently managing multiple complex projects undertaken by outside vendors. - Drive cost effective, technically sound manufacturing, packaging and/or distribution activities. - Supplement internal capacity by effectively coordinating, integrating, communicating, monitoring/measuring, reporting and streamlining the process by which investigational products are progressed from formulation to tangible clinical supplies through strong, strategic relationships outside of the company. MAJOR ACTIVITIES AND RESPONSIBILITIES: FINANCIAL AND CAPACITY PLANNING: - Working with planning, seek and review annual activity forecast from Clinical customer base. - Set up cost estimates and budgets for forecasted work on an annual and ad hoc basis. - Initiate Request for Outsourcing and budget from finance (RFC process) for outsourced projects when applicable. - Ensure budget is maintained and managed/updated when appropriate. CROSS FUNCTIONAL VENDOR ASSESSMENT AND QUALIFICATION: - Drive the recruitment and assessment of appropriate vendors from a cost and technical standpoint, participating in due diligence evaluations and approving vendors for GMP audit. - Set up GMP audit requests from quality unit (and attend where appropriate). - Initiate requests for MSA, technical/quality/confidentiality agreements with chosen vendors (monitoring progress and ensuring timely completion). PROJECT INPUT AND VENDOR ENGAGEMENT: - Provide technical expertise to internal project team,; delineate vendor capabilities and provide creative/key technical consultation into clinical supply strategy as required. - Co-ordinate submission of RFQ (request for quote). - Receive and review vendor quotation, provide technical feedback and drive vendor selection. - Ensure adherence to market value or agreed pricing arrangements for all services requested. - Attend (and manage where appropriate) vendor business review meetings, site visits and technical update meetings. - Independently review and approve vendor invoices. Ensure adherence to project budget. PROJECT MANAGEMENT AND DELIVERY: - Receive and independently review outsourcing request from internal personnel. - Manage clinical supply delivery timeline of clinical programs and/or multiple complex projects ranging from Phase I though IV in conjunction with chosen vendor to ensure customer expectations are met. - Work cross functionally, coordinating the necessary internal resources to ensure vendor timelines can be achieved and flag issues for resolution. Manage and mentor documentation specialists, troubleshooting issues where appropriate. - Resolve project issues from a technical and timing perspective and provide PM oversight (e.g. holds project review meetings as appropriate) to ensure timely availability of clinical supplies to meet Clinical Development program requirements. TRAINING AND PROCESS IMPROVEMENT: - Provide training/mentoring to new/existing personnel on technical activities concerning clinical supplies including outsourcing methodology. - As appropriate, participates in third party process re-engineering and process improvement initiatives to enhance efficiency and alignment with external and internal partners.

REQUIREMENTS: - Strong technical knowledge of clinical manufacture and project management - Experience in clinical trial supplies strongly preferred - Experience working in either a CRO or pharmaceutical company - Knowledge of clinical protocol and packaging design for supplies - Ability to handle multiple projects simultaneously - Strong written and oral communication skills - Good customer service skills ONLY APPLICANTS WITH THE ABOVE EXPERIENCE WILL BE CONSIDERED. Join Aerotek Scientific LLC(SM), one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.

Please refer to Job code allegis-1670374 when responding to this ad.

For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1645817.html?source=ng to apply online.

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