|
|
|
|
Senior Clinical Trial Manager Job
|
| Employer Name: BiotechCrossing |
SpiderID: 2339127 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/4/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5884514 |
|
Job Description:
Authors sections of clinical study reports and other clinical documents, and provides input for the design of the monitoring conventions, and edit checks, etc. Manages all clinical aspects of study including: Assesses operational feasibility and recommends study execution plan; Identifies, assesses and proactively manages operational risks; 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, 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. May act as global operational study leader, as required. May coordinate clinical portions of regulatory filings, as appropriate Develops relationships with investigators and site staff; Selects sites and countries (with Commercial input for phase II/III). 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.
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
Sign Up Now
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
|
|
|
|
|
|
|