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Clinical Trial Manager II
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Organization: Clinical and Systems Resource Group
View Company Profile of Clinical and Systems Resource Group :: View more jobs from Clinical and Systems Resource Group
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Job Description:
The Clinical Trial Manager III is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities.
Job Duties/Responsibilities:
- Performs job duties independently with minimal guidance from the Clinical Program Manager.
- Leads the Protocol Execution Team (PET) to ensure that trial timelines, costs, and quality metrics are met
- Serves as primary contact for functional area representatives in managing protocol execution
- Ensures accuracy and timeliness of vendor and site payments
- Oversees forecasting of clinical/non-clinical supplies
- Establishes study milestones and ensures accurate tracking and reporting of study metrics
- Manages trial-specific collaborations with other research entities (e.g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials)
- Performs ongoing vendor management (e.g., CROs, IVRS, Reading Centers), including independent negotiation of vendors scope of works and budgets, performance management, and issue resolution
- Creates and manages clinical trial budgets and staffing/resourcing plans
- Provides study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate
- Provides support and mentoring to other Clinical Trial Managers
- Ensures trial adherence to ICH/GCP/local regulations
- Participates in clinical operations initiatives and programs as assigned
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Skills Required:
Competencies Identified for Success:
- Highly developed leadership skills to build and directs the Protocol Execution Team to ensure that timeline, cost and quality metrics are met
- Effective written and verbal communication skills
- Extensive experience developing trial plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners
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Qualifications:
Education, Experience, and Other Requirements:
- Bachelor's Degree with a minimum of eight years of clinical research experience
- Therapeutic knowledge preferred
- Knowledge of GCP and ICH
- Proficient computer skills
- Travel may be required
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| Job Category: |
Biotechnology |
| Job Status: |
Full Time |
| Location:
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South San Francisco, United States |
| Start Date:
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ASAP |
| Salary:
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125,000 - 140,000 |
| Contact:
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Andrew Mammano |
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Email: |
Andrew@srgr.com |
| Reference:
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CTM II SF |
| Date Posted:
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8/28/2008 6:53:36 PM |
| Duration:
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