PRA’s Central Review Services team, unique in the CRO industry, offers lupus-specific expertise in protocol and endpoint design, standardized central medical review and grading, efficacy data cleaning, and investigator and site training. Since 2006, this physician-led team has supported multiple global Phases I-III clinical studies in over 4,500 subjects with generalized SLE and lupus-related diseases, including nephritis and arthritis. The team is solely focused on delivering independent, centralized endpoint data evaluation, grading, and data management for SLE clinical and laboratory endpoints including: BILAG; SLEDAI; SLEDAI Flare Index; SLICC; and other assessment tools. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.
The Medical Reviewer/Director of Therapeutic Expertise will work within a multidisciplinary team to support client deliverables, including grading services for efficacy indices, business development, communication and training. Extensive experience with global clinical trials is desired. This should include but not be limited to study start-up activities including site selection and set up, investigator meeting experience, study conduct phase, data analysis and close out activities. The ability to travel domestically and internationally and to present to global audiences is strongly preferred.
- Medical Degree (MD) required
- Therapeutice expertise in Rheumatology is preferred but other complex medical indications will be considered
- Substantial CRO, biotech or pharmaceutical experience including project leadership and interaction with therapeutic and medical experts required
- Excellent verbal and written communication
- Ability to present and train global audiences
- Ability to work independently with minimal supervision
- Ability to travel domestically and internationally