Description
Roles and Responsibilities:- Act as primary liaison to CROs and vendors for assigned clinical studies/programs
- Coordinate activities with the company's development partners, CRO and global clinical sites from study initiation to close out
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
- Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, annual regulatory reports, etc
- Assist in the development, forecasting, monitoring, and reporting of assigned clinical trial budgets
- May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff, and with compliance personnel
- Travel as required to domestic and international development partners, CROs, vendors, and clinical sites, as needed (***approximately 40%)
Requirements:
- BA/BS and direct relevant experience in global drug development required, advanced degree (MS) in a life science major is preferred
- 5-8 years of experience of biotech/pharmaceutical clinical operations experience
- Must have experience in managing the execution of complex phase 1-3 global clinical trials, preferably in inflammation or oncology-related clinical therapeutic areas
- Team-oriented with excellent communication and interpersonal skills
To find out more about Real please visit www.realstaffing.com