Sr Clinical Data Mgr (DG)
Boston, MA - Pharmaceutical & Biotech - Remote - Full time
Date Posted: 1/31/2024
Senior Clinical Data Manager
The Senior Clinical Data Manager will lead all data management activities for assigned clinical studies, insourced and/or outsourced. Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time, within budget, and aligned with quality standards. Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints. Drive the development of high quality eCRFs in consultation with a cross functional team that accurately reflect the data collection requirements defined in the study protocol and that are consistent with internal standards. Oversee database design activities to ensure it meets requirements for the entry and reporting of clinical data. Develop and review Data Management Plan (DMP) and associated appendices to ensure data quality and integrity. Develop/Review eCRF Completion Guidelines (eCCG) to serve as an aid for site personnel to record data in the Electronic Data Capture (EDC) interface. Perform User Acceptance Testing (UAT) of the database design including eCRF contents, database configuration (edit checks, derivations, dynamics, structure, blinding and permissions) to ensure the quality and integrity of the clinical study database. Conduct and Oversee data review and associated query generation esolution. Represent Data Management and actively participate on Clinical Study Core Team meetings for all study activities. Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts including risk mitigation strategies. Develops specification and collaborates with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study. Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan. Review study data for completeness and clinical feasibility. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations. Lead/Author the creation and review of departmental SOPs, Work Instructions, and training materials. Identifies opportunities for standardization and takes initiative to help improvement departmental efficiency. Identify trends in data completion and work with CRAs and/or site personnel to help improve the quality of the data collected. Demonstrates project management skills and balances the triple constraints of time, cost and quality. Demonstrates an understanding of data structures, database design constraints and needs of SAS Programmers/Statisticians. Defines and reviews CRO/Vendor scope of work and provides input into study contracts. Constructively challenges process and assumptions to cultivate development and implementation of refined solutions. Provides feedback on process, execution and performance to foster continuous learning and growth of self and team. Provides mentoring/coaching of new hires and/or junior associates. Maintains accurate and complete study records. Ability to perform additional responsibilities as requested.
Bachelor’s degree from an accredited university required; BS preferred in Life Sciences. Minimum of 5 years data management experience in CRO, pharmaceutical, biotechnology, or medical device industry. 1. Prior knowledge and experience with Medidata RAVE required. Experience with other Medidata platform applications including TSDV, Imaging (MMI), RTSM, TSDV, and CTMS desired. Experience with Veeva Vault electronic Trial Master File (eTMF) desired. Experience with JReview and Business Objects desired. CRO/vendor management experience desired. Knowledge of GCP and FDA Code of Federal Regulations required. Knowledge of International Regulations desired.
Please contact Darren Gutowski at email@example.com