- Vendor management (such as CROs, Central labs, Central imaging, IVRS, EDC) including the outsourcing process from RFP to budget negotiation
- Investigative site selection
- Clinical timelines as identified by senior management
- Developing and reviewing Standard Operating Procedures and Guidelines
- Review clinical data
- Assist Regulatory Group with preparation of NDA/BLA
- Developing and reviewing clinical section of Investigator brochure
- Manage clinical staff including contractors and regional CRAs
Services I can provide within clinical operations: