- Management of clinical research project.
- Vendor (CRO, Lab, drug storage, etc.) supervision and management.
- Liaison with KOLs.
- Support IND and NDA filing.
- Quality control of the clinical research projects, such as co-monitoring.
- Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
- Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
- Input operational part of the protocol for trials.
- Review and approve study CRFs.
- Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
- Contact with CMC department regarding design of labeling, packaging and drug logistics.
- Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
- Select clinical trial site and keep good relationship with investigators.
- Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
- Support contract negotiation with study sites.
- Select and cooperate with statistician to conduct data analysis when required.
- Participate in regular Data Quality Review Meetings.
- Coordinate final trial report.
- Support CRO Selection.
- CRO supervision at the trial level.
- Support IND and NDA filing: Document review and progress tracking.
- Do co-monitoring visits for the project.
- Review monitoring reports.
- Check TMF before archiving.
- At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
- At least 3 years industry experience with proven proficiency in clinical research management for drug development.
- Good understanding of ICH guidelines, GCP and regulatory requirements.
- Excellent planning, organization and problem solving abilities.
- Good communication and interpersonal skills.
- Proficiency in English and familiarity with standard IT office tools.