Experience in developing and managing
- Service providers (such as, CROs, Central labs, Central imaging, IVRS, EDC) including the outsourcing process from RFP to budget negotiation
- Investigative site selection
- Clinical timelines
- Standard Operating Procedures and Guidelines
- Clinical section of IND
- Final Study report
- Review clinical data
- Clinical section of BLA/NDA
- Clinical section of Investigator brochure
- Review monitoring reports and follow up on issues documented
- Assist Regulatory Group with preparation of INDs and NDA/BLA
- Clinical staff including contractors and regional CRAs