1. Providing leadership and clinical input on Japan project team and global project team.
2. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
3. Assist with preparation of clinical study report.
4. Review literature and prepare summary documents for inclusion in IB, regulatory submission documents, etc.
5. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
6. Collaborates and supports clinical operational activities including but not limited to study documents preparation, medical monitoring, and team communication.
7. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
8. Participate and present at investigator meetings
▪ Minimum 2 yrs. experience in medical or technical writing
▪ Clinical study manager experience preferred
▪ Excellent written and verbal communication skills in English and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
▪ Extensive medical/scientific and clinical research knowledge
▪ Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
▪ Proficient at data interpretation
▪ Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
▪ Knowledge of GCP and ICH Guidelines
▪ Experience in presenting at Investigator Meetings