Senior Clinical Trial Manager Job

Employer Name: BiotechCrossing	SpiderID: 2339131
Location: Cambridge, Massachusetts	Date Posted: 7/4/2008
Wage:	Category: Biotech
Job Code: 5851285

Job Description:
Leads the SMT to design clinical trial protocols consistent with the clinical development plan; develop an ongoing data review plan to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met; Participates in the ongoing and final review of clinical study data and assessment of the impact of this data to the study and program. Authors sections of clinical study reports and other clinical documents, and provides input for the design of the Acts as key operational interface with partner companies, as appropriate. 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 condition of clinical trial documentation including central clinical files; Reviews monitoring reports to ensure quality and resolution of site-related issues; Coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.Coaches and mentors Clinical Trial Coordinators (CTCs) and CTMs; Manages clinical project personnel

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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

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com