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Clinical Project Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2355179 |
| Location: Morgan Hill, California |
Date Posted: 7/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6020184 |
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Job Description:
Also includes responsibility for Medical Device Development study documentation including Human Factors usability study protocols and SOP s. Also includes planning and coordination of Scientific Advisory Board (SAB) meetings related to device development projects 1. Supervise the development and execution of clinical studies, customer preference studies and development site partnership studies, for all device projects. a. Prepare project plans. b. Interface with IRB s and Investigators to obtain study approvals. c. Assume lead role in project planning for all device studies including assessment of clinical team headcount, project timelines and effective utilization of budget. d. Management of Clinical Research Associates to include project assignment, professional development, performance management, coaching and mentoring. e. Review and approval of subject consent forms. f. Effective communication of project related information including the planning and execution of meetings and presentations. g. Coordination and completion of scientific documents to include protocols, clinical study reports, case report forms, investigators brochures and other regulatory documents. h. Assist in the development of clinical sections of regulatory filings including PMA s, IDE s, etc. i. Review and approval of subject consent forms. j. Monitor device distribution and accountability. k. Site Initiation visit and education of site personnel concerning protocol and case report from completion as well as study expectations. l. Track subject enrollment and study progress in accordance with study timelines. m. Manage study completion activities to include case report form collection, query resolution and site closeout activities. n. Ensure essential document collection and review is complete. May supervise activities of the Document Specialist. o. Author clinical study report writing, including data interpretation p. Assist with outsourcing activities including Clinical Research Organizations, vendors and consultants, which includes review of proposals, contracts and budgets. q. Interface with device Marketing Managers / Directors, and with R&D Program Managers, soliciting input regarding SAB needs, timing, expertise required, etc. Plan and coordinate the Advisory Board meetings. r. Collaborate with Device Development Specialists to develop Medical Device Development documentation including Human Factors usability study protocols and SOP.
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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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