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Assistant Manager, Clinical Operations Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298688 |
| Location: Clinton, New Jersey |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5319488 |
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Job Description:
Responsibilities include, but are not limited to, 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; 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. Requirements: BS or RN (4 year degree), advanced degree preferred. 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.
For more information, please click here To visit us at BiotechCrossing.
For further information, please visit us online at http://www.biotechcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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