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Clinical Trial Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2388277 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6731328 |
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Job Description:
Manages all clinical aspects of study including: Assesses operational feasibility and recommends study execution plan; Develops and manages comprehensive study timelines and metrics; Participates in selection and management of external vendors and develops vendor specifications; provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel; Prepares and presents project debriefings, as required; Plans, executes, and leads study-specific meetings (e.g., SMT, investigator meetings, Advisory Committee); Participates in site monitoring visits as appropriate. Uses operational and therapeutic expertise to optimize trial design and execution: Works with the SMT to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met; Prepares study-related documentation; Provides input for the design of the ICF, CRFs, monitoring conventions, edit checks, etc. Develops relationships with investigators and site staff; Selects sites and countries (with Commercial input for phase II/III). Works with Business Analyst to develop and manage study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget. Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: Participates in the planning of quality assurance activities and coordinates resolution of audit findings; Ensures audit-ready.
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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: |
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Web Site: http://www.biotechcrossing.com
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