Sr. Data Manager or Principal Data Manager JOB SUMMARY: Coordinate and perform data management tasks from study start-up through database lock, including database set-up and data validation as per the requirements in the clinical protocols and ensure timely delivery of high-quality consistent data. Lead all portions of a project and/or multiple projects with minimal or no supervision. JOB RESPONSIBILITIES: Adherence to SOPs and maintaining audit-ready documentation. Coordinate and oversee activities of all DM staff assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget. Attend relevant project meetings and work closely with other internal and external leads. Liaise with client/partners for clarification on any clinical and/or technical decisions and propose most efficient solutions. Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks. Create DM timelines for database set-up. Lead and participate in the design of Clinical Electronic Data Capture (EDC) components including mock CRF, casebook, edit checks. Coordinate and create data management documentation including Data Management Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection System Configuration, Data Transfer Agreement. Coordinate and perform User Acceptance Testing. Train EDC users. Manage EDC users' access and assist with resolving issues. Coordinate all conduct Data Management tasks. Lead and participate in data cleaning activities including SAE and external data reconciliation. Provide input to protocol and assess database impacts based on protocol changes during study lifecycle; prepare and execute change request forms. Lead and participate in Database Lock activities, including timelines creation, QC coordination and Data Management Report creation. Contribute to departmental procedures and guidelines. Critically evaluate data management needs and propose appropriate, innovative, and efficient data management solutions. Train and mentor less experienced staff. Represent Cytel at project, proposal, or industry meetings. May participate in the recruitment process. Contribute to budget evaluation for proposal writing purpose and be Data Management representative during bid-defense, as needed. Support senior team members and/or be the data management representative during audits. May act as a line manager, contribute to the development of a strong team of data managers, by functionally managing and guiding the data managers with respect to data management strategy, deliverables, processes, and professional development. #J-18808-Ljbffr
