Job Summary
A pharmaceutical company is in need of a Remote Clinical Development Director.
Candidates will be responsible for the following:
- Summarizing data and contributing to Clinical Study Reports
- Providing support for medical monitoring of assigned clinical trials
- Designing clinical studies and writing synopses, protocol and amendments
Skills and Requirements Include:
- Attendance at teleconferences and face-to-face meetings with global regulators
- Extensive experience with compliance issues
- Minimum of 10 years of clinical development experience
- Experience providing input into key regulatory documentation
- Strong understanding of FDA regulations, GCP and/ SOPs in clinica lresearch