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Clinical Affairs Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2217370 |
| Location: Bedford, Massachusetts |
Date Posted: 5/8/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
This position will assume responsibility for the design and implementation of clinical trials to demonstrate medical product safety and efficacy. Specific Responsibilities: Provide operational perspective to planning of clinical studies. Develop and review clinical study protocols and obtain IRB approvals, as necessary Establish timeline and cost estimates for clinical studies. Manage budget for Clinical Affairs resources and the conduct of clinical studies. Overseeing clinical studies as necessary. Participate in site selection and qualification. Monitoring clinical sites, as needed, including pre-investigational site visits, initiation visits, interim visits and study closeout visits. Conduct site and vendor (CRO and central lab) audits. Plan, monitor and report patient enrollment and implement corrective actions as necessary to meet enrollment targets. Manage contractual negotiations for all clinical studies involving outside parties. Prepare clinical study agreements to gain approval for standard and non-standard contract language. Act as the key interface with Clinical Research Organizations (CROs). Coordinate all GCP activities from site selection through data completion and regulatory site audits with CROs. Lead the preparation of clinical documents for regulatory submissions. Coordinate generation and assembly of all documentation associated with clinical studies, such as protocols, case report forms, informed consent documents, investigator agreements, investigator brochures.
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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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