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Manager, Clinical Operations Job
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| Employer Name: BiotechCrossing |
SpiderID: 2206751 |
| Location: Somerville, New Jersey |
Date Posted: 4/28/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
The Manager, Clinical Operationsensures efficient and high quality generation of clinical data in support of the global Ethicon Franchise and JNJ Umbrella businesses; develop strategic and tactical approaches for utilization of global resources for planning and conduct of regional and local studies. Collaborates with Director Clinical Development, Biostatistics, Data Management, Clinical Managers, Project & Data Managers, Regulatory Affairs, Finance, Quality Assurance, Information Management and Compliance. The Manager, Clinical Operations is responsible for designing, developing and maintaining global clinical operations architecture and infrastructure. Oversight of Clinical Administration Project Managers, Coordinators and other assigned personnel. Resourcing allocation for regional / local clinical study plans including budgets, personnel and vendors. Allocating resources to projects based on business priority, clinical plan and geographic spread of clinical sites. Implementing infrastructure to ensure high standards of research conduct and compliance requirements. Overseeing and coordinating study supply requirements and reconciliation according to CFR/GCP/ICH requirements, including study article procurement and tracking through study implementation, monitoring and closure. Ensuring development & maintenance of all critical inter-company, intra-company and external interfaces and processes in clinical research. Overseeing Vital Documents retention and records management processes. Clinical study financial management: budget creation and maintenance, accruals, reporting.
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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: |
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Web Site: http://www.biotechcrossing.com
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