主要职能 Primary Function:

To support Departmental business needs identifying by management team or other special assignments/tasks.

主要职责 Major Responsibilities and Duties:

• Proficiency in Data Management activities including data review, query management, third party data reconciliation, SAE reconciliation etc without support; Perform Coding with support

• Generate listings and metrics report for data review according to Data review plan without support from Data Management project lead;

• Working independently or minimum help in database validation activities including screen lay out testing and procedure testing and can deliver all DM activities within timeline and high quality;

•Create, review and revise data management documentation independently or with minimum support from Data Management project lead;

• Ensure work carried out in accordance with applicable SOPs and working practices.

• Ensure the required study-specific DM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.

• Mentor new DMs in multiple DM tasks (including but not limit to: UAT, data review, query management, third party data reconciliation, SAE reconciliation, IRT reconciliation etc) and administration.

• Act as a trainer within DM internal team to provide introduce of DM task(s)

• More than 2 years of related experience in clinical data management or equivalent in the Biopharmaceutical or CRO
• Bachelor or Master’s degree in a health care or scientific related field preferred.
• Proficient in data management activities including CRF and clinical database design, clinical data cleaning and Data Set Release for Oncology trials are preferred
• Experience using clinical data management systems and/or EDC products (RAVE preferred)
• Demonstrates strong verbal and written communication skills including ability to communicate remotely.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Experience using data visualization tools (e.g. Spotfire, J-Review, JMP) preferred
• Demonstrated knowledge and understanding of clinical development process including but not limited to GCP, NMPA, HGR, FDA, ICH, GCDMP, CDISC, WHODrug, MedDRA are preferred.
• CET-4 is required. CET-6 is preferred.