Description
Responsibilities:- Work with clinical team and senior management to develop and implement project resourcing plans to ensure efficient and cost-effective trial management
- Contribute to the development and management of the clinical department budget and resource needs
- Contribute to building the clinical infrastructure including policies, procedures, SOPs, guidelines and cross-functional communication
- Management of clinical team staff with direct reports
- Provide senior management and functional leads with updates on study progress at a high level including milestone measurements against timelines and budgets
- Generate and direct clinical timelines
- Identify and implement methods for improving communications/sharing ideas/ work flow across departments and clinical team
Requirements:
- BS/BA , RN, or equivalent with at least 5 years clinical management experience (diagnostic experience preferred) in accordance with CFR, GCP and ICH Guidelines
- Organizational skills necessary to implement and coordinate clinical trial activities.
- Experience in working for sponsors and managing CRO and other vendor relationships required
- Experience managing a team of clinical trials professionals
- Flexible; adapts work style in order to meet department and company needs
- Experience in the interpretation of clinical study results; facilitating/writing of clinical reports.
- Excellent protocol writing and case report form design.
- Computer proficiency (MS Word, Excel) required. Experience with MS Access and MS Project a plus.
- Ability to travel up to 35% (all West Coast)
To find out more about Real Staffing please visit www.realstaffing.com