经理/副经理，数据管理

Role Overview:

Serves as sponsor-side DM, working with or supporting the DM OM (oversight manager) in overseeing CRO’s clinical data management activities and deliverables for local and global single/ multi-center clinical trials. Ensures clinical data delivery complies with company data quality and integrity standards, project timelines and budget requirements.

Key Responsibilities:

 Oversee all DM aspects for Everest projects and ensure effective quality oversight and management of external partners (e.g. CROs, technology providers, etc.) throughout the whole project life cycle.

 Support EDC system eCRF, edit check and other components build (including perform UAT from sponsor perspective) to ensure set-up process consistent with clinical data model, statistical analysis plan etc.

 Review and approve key study documents, including Data Management Plans (DMPs), Data Validation Plans, CRF specifications, data review guidance, vendor data transfer agreement, Database lock checklist etc.

 Collaborate with CRO/external vendor and cross functional team to monitor data quality for both EDC & non-EDC data to ensure deliver accurate, timely, consistent and quality clinical data.

 Identify DM risks and proactively implement solutions to support successful study execution from start-up till close-out.

 Maintain study documents systematically (i.e sharepoint /eTMF etc) to ensure accurate, complete and traceable records of all project activities.

 Contributes to the development and improvement of DM process, standards and vendor oversight practices.

Requirements

Bachelor degree or above, major in Pharmacy, Biology, Clinical Medicine, Nursing or other life science related disciplines.

6+ years clinical data management experience.

Hands-on experience on EDC system (Medidata Rave / Veeva etc.), familiar with DMP, eCRF design, edit check, query management, DB lock process etc.

Experience with tumors is preferred.