I can contribute with many years of experience with execution, development, conduct and reporting of clinical trial within many disease areas and development stages (phase II to IV).
Special areas of interest:
Clinical trials
- Leading clinical trial teams (phase II-IV)
- Contributing to clinical trial design
- Contributing to evaluations of new indications
- Planning and execution of expert advisory boards for protocols and evaluation of endpoints
- Collaboration on writing of trial protocols
- Input and evaluation of crfs and e-crfs
- Input to request for proposals from vendors
- Participation in bit defense meetings and vendor selections
- Collaboration with CROs and CRAs
- Planning and conduct of investigator meetings
- Planning and conduct of clinical trial site training
- Overseeing clinical trial conduct
- Medical responsibility for clinical trials
- Clinical trial result review and evaluation
- Clinical trial report development
- Presentation of clinical trial results
- Collaboration with experts for evaluation of protocol design and study results
- Coordination and execution of clinical trials at investigator sites
- Contribution to clinical development plans
