Description
Throughout the clinical program life cycle, provides data management leadership for global clinical projects and is responsible for the data quality, integrity and accuracy. Responsible for developing and maintaining data quality standards and respective standard operating procedures as well as for ensuring the adherence to the standards by external vendors. Oversees the design and conduct of EDC studies developed by external vendors with regard to Company's data collection and management standards. Acts as the liaison between clinical, biostatistics, clinical safety, and clinical development teams and external vendors for data management matters.Leadership of the overall data management operations process supporting projects/programs for clinical studies within the scope of project timelines
Supports improvement initiatives to enhance efficiency and quality of the group's deliverables.
For a given project: implements and maintains internal data management standards (including EDC and CDISC), external data transfer and acceptance specifications, and documentation processes for clinical data (based on the agreed clinical standards). If needed, develops new standards in close collaboration with the standards & programming group
Collaborates with clinical project teams and the clinical standards group in developing and/or defining data structure, ongoing data quality standards and clinical data acceptance rules for specific clinical studies.
Oversees project specific database design and eCRF builds according to CSL's Clinical Standards. Oversees the testing of data management system edit/validation checks and special listings/procedures used as tools for data review and discrepancy management activities.
Responsible for the generation or review of Data Management Plans, Data Validation Plans and Quality Management plans to deliver accurate, timely, consistent quality data.
Oversees the provision of project specific data management status, cycle time and productivity metrics by working closely with Data Management vendors. Monitors these deliverables, provides immediate feedback and requests potential actions.
Supports the development and maintenance of clinical data management operations and cross functional Standard Operating Procedures and related QMS documents.
Independently, initiates, manages and coordinates the activities of all external vendors that will process and transfer clinical data to CSL. Act as the primary point of contact for liaison with these vendors per study.
Ensures quality and consistency of clinical data through appropriate processes.
To find out more about Real please visit www.realstaffing.com