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| Employer Name: ManagerCrossing |
SpiderID: 2389947 |
| Location: Bridgewater, New Jersey |
Date Posted: 7/23/2008 |
| Wage: |
Category: Miscellaneous |
| Job Code: 6711744 |
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Job Description:
Develop, implement and evaluate standardized processes to ensure: adequate oversight of CRO delegated tasks, CRO compliance with SOPs and work instructions, compliance to contractual obligations, effective communication plan templates and selection of qualified CRO staff. - Liaise with ICTMs to ensure quality process consistency in the operational development and implementation and oversight of outsourced activities including but not limited to: scope of services document completion, bid defense meetings, contract finalization, study kick-off meetings, intervention meetings to ensure successful outcomes, and monitoring, communication, issue escalation, corrective action and risk management plans. - Collaborate with the CRUs to develop and maintain standardized systems to procure necessary country resources to support specific CRO study start-up/maintenance activities such as: translation/validation of IP labels, power of attorney, letter of delegation, local Informed Consent Form, the creation of investigators in Profile, insurance certificates, CT A submission and submission of expedited safety reports - Support CCS to ensure: develop and maintain CRO training process on required corporate SOPs, develop and maintain a tracking tool on the comparison of CRO SOPs to corporate SOPs. Collaborate with CCS to: develop and implement SOPs/Guidance documents to streamline CRO management practices and ensure new or existing SOPs/work instructions adequately address CRO involvement in the clinical trial management process. - Collaborate with suppliers to implement best practices/lessons learned with consistency and standardization of process. Plan, promote and organize ICTM training activities related to outsourced lessons learned.
For more information, please click here to visit us at ManagerCrossing
For further information, please visit us online at http://www.managercrossing.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: ManagerCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.managercrossing.com
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