Position Summary

This position will serve as the technical leader on all data management aspects for Everest project(s) and ensuring effective quality oversight and management of external partners (e.g. CROs, technology providers, etc.) performing data management services on behalf of Everest including start-up, maintenance, and completion activities and development of Data Management Plans and Data Management Report (if needed) that will deliver accurate, timely, consistent, and quality clinical data.

Key Responsibilities

 Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and participate in the development of the clinical data model and/or database design.

 Interact and collaborate with other project team members (clinical, statistics, PM, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.

 Coordinate/oversee the development and testing of data management systems edit, data validation checks/diagnostics and special listings/procedures used as tools for the data review and discrepancy management activities.

 Review data acquisition conventions and data review guidelines, setup processes to be consistent with the clinical data model, statistical analysis plans, and CRF (eCRF) completion

 Oversee the technical performance of the CRO data management staff on delivering of quality data, on-time and on-budget.

 Review literature and research technologies/procedures for improving global data management practices.

 Master with 8+ years of relevant (DM or lead DM) pharmaceutical industry experience.

 Demonstrated familiarity with electronic data capture systems (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

 Demonstrated experience with industry standards, e.g. SDTM/CDISC, CDASH, and good understanding of database and dictionary structures (e.g. MedDRA, WHO-DD).

 Good understanding of the drug development process with proven expertise in clinical trial data management.

 Demonstrated partnership across various collaborative forums, CROs, and/or local site networks.

 Excellent oral and written communication and presentation skills in both Chinese and English.

 Experience with clinical trials in both oncology and non-oncology and from Phase I to Phase III.