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.
Responsibilities
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.
Qualifications
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.