? Manage clinical trials data or data management projects under timelines in a high quality and professional manner. Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
? Oversee Data Management vendors – review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
? Lead regular data review meetings in a cross-functional team environment.
? Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
? Oversee the design, creation and testing of clinical study databases, responsible for creating and adhering to Data Management timelines and budget.
? Review protocols for proper data capture including electronic Case Report Form design. Able to perform a thoroughly detailed review of eCRF data requirements. Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans etc.
? Designs and/or reviews eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans, Data Surveillance Plan, detailing complete data management processes throughout clinical studies.
? Create/Oversee development of data edit check specifications and manual data listings as required.
? Responsible for data cleaning, query and resolutions, review of medical coding, database lock activities
? Responsible for lab reconciliation, manage and reconcile external data, authoring data transfer agreements, and ensuring study documentation to be filed in the eTMF
? Working with Safety/PV function to develops study specific Serious Adverse Event (SAE) reconciliation guidelines, reconciles SAEs, comparing events across the clinical database and drug safety database, addressing any discrepancies, as per SAE guidelines
? Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable.
? Proficient working knowledge of any of the following strongly desired: SAS, Spotfire or other Visualization Tools, Data Standards management, SDTM
职位要求：
? Bachelor or Master degree in a health care or related field
? +5 years of clinical data management experience within Biopharma/CRO environment. Oncology/Immuno-Oncology experience is preferred.
? Team player who effectively works with colleagues in clinical, clinical operation, and statistics function