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Job Title: Asst Manager/Manager, Clinical Operations
Job Location: NJ: West Portal
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-20

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Asst Manager/Manager, Clinical Operations



The responsibilities for the Asst Manager/Manager, Clinical Operations position include: leading clinical operations team for assigned studies ensuring project timelines, study files, site budget and reporting processes are being maintained according to established procedures; preparing Clinical Monitoring, Site Management Plans and Pharmacy Plans including actions for study start-up, recruitment, monitoring and site management and quality data deliverables; establishing and monitoring enrollment timelines for assigned studies; training CRAs for assigned studies in study requirements (investigator selection, feasibility assessments, initiation, monitoring, site management and close-out activities); coordinating the ordering label review, and packaging of drug supplies; identifying areas where resources or progress are not consistent with the operational plan, and helping team and management correct any divergence from time lines; communicating up-to-date information regarding operational progress to all relevant interested parties; liaising with study team members on operational issues, obtaining necessary input from Clinical Science; Data Management and others as necessary; providing information for preparation of study budgets and third party vendor agreements; working with the Outsourcing Group to identify vendors, negotiating terms and conditions for performance of outsourcing responsibilities; ensuring adequate and timely performance by CRO/Vendor; reviewing and approving all monitoring reports for assigned studies; managing, tracking and reporting on overall site budgets at regular intervals; driving and facilitating cross departmental work and communications to assure timely attainment of study milestones; conducting operational team meetings at regular intervals with CRAs, Documentation Specialists and others as needed; attend relevant symposia, conferences and scientific meetings as necessary; ensuring that company SOPs, GCPs and ICH guidelines are adhered to; contributing to training activities and process improvement in Clinical Operations and participation in other tasks as needed. The ideal candidate will have the following skills and experiences: BS or RN (4 year degree), advanced degree preferred. Must demonstrate competence in cGCPs and have at least 6+ years of clinical research experience with the biotech/pharmaceutical/CRO industry including experience as a Lead CRA. Demonstrated computer skills in MS Office. Excellent relationship building, supplier expectation management, resource planning, collaboration, negotiation, conceptual and systems process thinking, conflict resolution, presentation and communication skills. Ability to work effectively in a matrixed innovative and flexible environment, excellent verbal and written communication skills, experience presenting, knowledge of continuous improvement principles, creativity in problem solving, ability to work effectively in a team/matrix environment are imperative.

Please refer to Job code TP5788 when responding to this ad.

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