Provides DM functional support to help deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the trial.
Interfaces with the project team and sponsors across the lifecycle of the project to proactively ensure data integrity and quality.
Mentors more junior DMs and other project team members on areas related to data management.
Works closely with lead DMs and other lead project team members to ensure project execution and sponsor satisfaction.
Effectively aides in presentation of information and response to questions from sponsors, senior managers, project team members, and clinical trial sites.
Ensures compliance with standard operating procedures.
Aides in design of eCRF and reviews with lead DM and study team to ensure design is robust and minimizes risk. Works particularly closely with the lead DM and statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design.
Helps in creation and implementation of data management plans (DMPs), data entry guidelines, data completion guidelines and other study documents.
Along with lead DM, manages electronic data capture (EDC) system design, development, testing, and validation, including oversight of all database specifications (eCRF, SDTM where applicable, edit check, external transfer, randomization, etc.).
Defines clinical database variables (type, format, univariate validation checks) from an annotated CRF using either DMS or EDC data dictionaries.
Assists in reviewing and approving creation of all edit checks, including validation of simple univariate and multivariate edit checks, programming of complex multivariate validation checks, and UAT of system edit checks. Ability to write simple edit checks using SAS or similar languages is required.
Reviews recommended data management tools and selects the best tools for the study, leveraging study metadata and automation to minimize manual error and facilitate deeper understanding of study data.
Uses data cleaning tools to identify data trends and potential issues early in the study, and implements intervention plans with project team to address issues.
Holds periodic multidisciplinary data reviews with the project team to review data trends and anomalies, and to proactively address risks.
Follows-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure.
Aides in conduct or oversight of completion of all activities for database lock, ensuring data integrity and adherence to applicable regulations.
Ensures all study materials are finalized in an eTMF and archived for delivery.