Description
The Senior Clinical Trial Manager will independently manage a phase II clinical trial in the area of dermatology.- CRO / vendor selection and management
- Participates in meetings and conference calls with CROs, vendors, and multi-functional teams
- Independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms
- Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance
- Ensure study timelines, costs, and quality metrics are met
- May contribute to development of abstracts, presentations, and manuscripts
Requirements:
- Minimum 5 years clinical research experience in the Biopharma indusry
- 3+ years experience managing Phase I-III clinical trials
- Bachelors Degree minimum; scientific discipline preferred
- Experience on the sponsor side as well as CRO
- Strong vendor management skills
- Strong knowledge of ICH / GCP guidelines and regulations
- Available for some travel, up to 25%
- Experience managing psoriasis clinical trials strongly preferred
To find out more about Real please visit www.realstaffing.com