Senior Data Manager

Role Summary

The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies. The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies. In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time.

Responsibilities

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissioning
• Conduct oversight of data management activities performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Lexeo obligations and business objectives throughout study life cycle
• Ensure the CRO and other internal and external partners align and conform to data management expectations for the assigned compound and/or indication
• Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs
• Proactively drive quality and efficiency, set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones. Ensure inspection readiness at all times
• Set expectations and communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals
• Follow department and company SOPs, forms, templates and policies. Provide feedback and update these guidelines as needed
• Develop, review, and maintain all study Data Management documentation
• Coordinate with Database Developers to ensure effective database build and timely go-live to meet the needs of the project
• Ensure the clinical database adheres to CDASH guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify gaps, and challenge unnecessary data collection
• Plan, perform and oversee development of specifications for eCRFs, edit checks, electronic data handling, manual review, and execution of User Acceptance Testing in collaboration with CROs and relevant functional partners. Define eCRF and edit check specifications to support data collection and analysis required per protocol
• Manage end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure deliverables are on time and of high quality
• Work with the CRO to ensure all data cleaning tools are in place for EDC, IRT, SAE and all external data sources to ensure consistency, accuracy, and integrity of clinical data. Take responsibility for and guide effective QC review and UAT of the clinical database prior to production, including oversight of staff performing these tasks
• Ensure data are properly reviewed in accordance with the DMP and guidelines and that cleaning is effective and timely
• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager
• Provide input into improving the efficiency of data management tasks
• Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives

Qualifications

• Bachelor's Degree in programming, health-related sciences, or relevant field and 7+ years of Data Management experience
• In-depth knowledge of industry-leading eCRF tools and familiarity with industry trends and emerging technologies supporting data collection
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Proven direct experience with data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables
• Analytical and problem-solving capabilities
• Excellent verbal and written communication skills
• Professional attitude and strong interpersonal skills
• Ability to work well with a multi-disciplinary team
• Flexible attitude with respect to work assignments and new learning
• Ability to prioritize workload
• Superior attention to detail
• Understanding of clinical research and the relationship of Data Management in the clinical study process
• Strong technical aptitude and ability to adapt to multiple data management platforms
• Strong knowledge of EDC clinical data management systems
• Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to adapt to various IT systems

Education

• Bachelor's Degree in programming, health-related sciences, or relevant field

Additional Requirements