Manage clinical trials data or data management projects under aggressive 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.
Develop/review data management functional SOPs and processes.
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
Bachelor or Master degree in a health care or related field
Minimum 8 years of clinical data management experience within Biopharma/CRO environment. Oncology/Immuno-Oncology experience is preferred.