北京招聘

Major Responsibilities
-Supports and works closely with study lead data manager(s) for assigned clinical studies.
-Performs data cleaning/reconciliation activities as specified in company procedural documents and study-specific Data Management (DM) documents.
-Manages queries on assigned clinical studies.
-Generates and delivers reports to study team members.
-Supports external data reconciliation, in addition to serious adverse event reconciliation.
-Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
-Supports the creation and maintenance of DM documentation (e.g., Data Management Plans, eCRF Completion Guidelines).
-Helps to ensure DM documents are filed per company Standard Operating Procedures (SOP) and Work Instructions (WI).
-Supports eCRF and edit check specifications development as necessary to support data collection and analyses required by the protocol.
-May work closely with database builders during clinical database build and programming of eCRF, edit checks, and reports.
-Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
-Participates in UAT activities for data transfers and programmed report outputs.
-Assists with Site and User management in clinical database of assigned clinical studies.
-May lead one or more Phase I to Phase II studies under supervision of manager.
-May work with vendors such as central laboratories in support of timelines and data-related deliverables.
-May help identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
-May help train other personnel on eCRFs and EDC.
-May help support development and maintenance of SOP and WI related to data management activities.
-Other duties as assigned.
职位要求：
Qualification
-Bachelor’s degree or equivalent in a health-related field
-3+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
-Oncology experience preferred
-Ability to work in cross-functional team-oriented environments
-Understanding for ICH and regulatory environment as it pertains to data management
-Experience with SDTM/CDASH
-Strong project management skills
-Excellent written, verbal and organizational skills
-Must be detail-oriented

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。