Description
Roles and Responsibility:- Act as the primary liason to CROs and vendors for assigned clinical studies/programs
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
- Contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, clinical study reports, INDs/CTAs, NDAs/MAAs, and annual regulatory reports
- 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/or with compliance personnel, including pre-study qualification visits, vendor qualification visits, routine study visits, trial master file review visits
Requirements:
- BA/BS and direct relevant experience in global drug development required (MS in life science is also preferred)
- 5-7 years of experience of biotech/pharmaceutical clinical operations
- Must have experience in managing the execution of complex phase 1-3 global clinical trials (oncology or inflammation experience preferred)
- Willing to travel domestically and internationally (up to 40 %)
To find out more about Real please visit www.realstaffing.com