Associate Director, Clinical Data Management
Duties and Responsibilities:
The Associate Director of Clinical Data Management is accountable for the overall DM strategy and implementation for high profile programs, as well as the management and mentorship of DM staff. This will include but will not be limited to providing resource strategies internally and externally for outsourced activities.
The major functions performed in this position are as follows:
• Provides operational leadership and takes full accountability of the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards.
• Mentors and manages a team of data managers, and acts as one of the functional representatives at internal and external meetings across the company.
• Develops global, harmonized SOPs and specific quality processes and procedures for Data Management.
• Ensures DM project documentation is in an audit-ready state.
• Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy. This will include reviewing and resolving all discrepancies.
• Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission by working with lead CRO data manager or equivalent.
• Ensures that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis including raw datasets and bookmarking annotated CRFs.
• Ensures clinical data within EDC is ready to lock and freeze as appropriate for statistical review, interim analysis, and or final database lock.
• Develops, maintains, and governs CDM standards (custom eCRF, CDASH, etc.).
• Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements.
• Participates in RFP development, contract negotiation and selection of DM and/or technology, as needed.
• Provides training of the CRF completion guidelines, EDC system at Investigators’ meeting and to internal and external project members as needed.
• Responsible for the supervision and growth of individuals within the data management department.
• Contribute to budget discussions and companywide processes
Education: Bachelor’s or Master’s Degree in a science/technical related field.
Experience: 10+ years of DM experience and 2+ years of supervisory experience or an equivalent combination of education and experience.
Technical Skills Required:
Knowledge and experience in the following areas:
• Experience leading teams supporting NDA and EMEA, etc. filings.
• SAS is a plus
• Expert in all EDC systems, CFR Part 11 compliance.
• Expert in choosing and using data review and cleaning platforms.
• Expert in coordinating data management activities for database lock.
• Expert ability to disseminate the importance of complex technical. Issues/solutions to the clinical study team and management.
• Expert in development and implementation of data standards and procedures is required.
• Experience using industry standards such as CDASH.
• Strong Knowledge of SDTM and ADaM datasets.
• Strong knowledge of drug development process.
• Proven success in management of data managers or CROs.
• Strong Knowledge of FDA/ICH guidelines and industry standard practices regarding data management