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International Clinical Trial Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298667 |
| Location: Bridgewater, New Jersey |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5509932 |
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Job Description:
The International Clinical Trial Manager (ICTM) is the clinical project manager working with Provide oversight of a clinical trial or (trials) to ensure progress according to trial timelines.Lead the clinical trial team (CTT) (including representatives from CROs/CRUs, Data Management, Pharmacovigilance, Therapeutics, Biostatistics, Pharmacokinetics and other relevant departments) for the logistical aspects of the trial. Collaborate with feasibility manager to facilitate study feasibility. Set up and manage external resources for the trial (i.e., Central Lab, IVRS, CRO, Meeting Planner). Ensure proper collection of data and documentation. Assure proper overview of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures. Define needs, tasks and responsibilities of external resources, review contracts, estimate costs of logistical aspects of the trial and tracking payments for operational aspects of the trial in collaboration with the Clinical Purchasing department. KEY INTERNAL/EXTERNAL RELATIONSHIPS company, CTT and Clinical Investigations members, Clinical Research Units (CRUs), Clinical Network Liaison Data Management, Statistics, Investigational Product, Regulatory, Pharmacovigilance, Finance, legal, Clinical Purchasing, Clinical Research Organizations (CROs) and other clinical trial vendors (eg IVRS, Central Laboratories), Academic Research Organizations, External Steering Committee Members, Key opinion leaders & medical advisors Requirements : KNOWLEDGE/SKILLSCapable of interacting effectively with scientists and managers from various disciplines; serve as internal consultant on assigned area and liaise with external organizations on projects. Field monitoring experience is preferred. Prior management and/or supervisory experience in clinical operations are desirable. At least two years of Project Management experience in Clinical Operations is requiredEurope: Master's degree + 6 years minimum clinical research experience.Field monitoring experience is required (approximately 3-5 years). Prior management and/or supervisory experience in clinical operations are desirable. Strong English communication skills (verbal and written if English is a second language). At least two years of Project Management experience in Clinical Operations is requiredKNOWLEDGE/SKILLS DESIRED BUT NOT ESSENTIALFluent in French language and culture.
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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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