This role will be responsible for the first in human new compound phase 1 trial management. This role is accountability for the study end to end delivery throughout study design, start-up, conduct, analysis and reporting, study site close-out.
1.Ensure clinical trial deliverables are met according to timelines, budget, operational procedures, and quality standards adhere to current regulatory guidance and GCPs.
2.Manage aspects of trial operations, including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the project team.
3.Manages the negotiation of contracts, budgets and timelines with CROs, clinical sites, and other external partners.
4.Manage activities associated with study start-up, conduct and closeout activities to industry and corporate standards and goals.
5.Contribute to the writing and review of study conduct related documents such as monitoring plans, CCGs, lab manual and pharmacy manual etc.
6.Review study invoices and manage accruals monthly.
7.Ensure Trial Master File documentation is collected and completed contemporaneously.
1.Bachelor’s level degree or above in life sciences, pharmacy, medical or related specialty including nursing and other biological background.
2.Minimum 5 years of experience in clinical trials management in MNC or a biotech or CRO.
3.Demonstrated knowledge and understanding of FDA/NMPA/GCP/ICH regulations and guidelines.
4.Strong operational skills with detail oriented and demonstrate the ability to deliver quality results in a timely manner.
5.Ability to take initiative and work both independently and in a team environment.
6.Excellent verbal and written communication skills in English and Chinese.
7.Strong multi-tasking, time management, and organizational skills.