Senior Director, Clinical Data Management
Editas Medicine
- Cambridge, MA
- Permanent
- Full-time
- As the Director/Sr. Director, Clinical Data Management, you will be responsible for:
- Provide leadership and drive strategic direction of Data Management
- Provide guidance and mentorship to direct reports
- Develop DM standards and procedures
- Review/approve DM-related documents (e.g. eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines), as applicable
- Manage DM resources and contracts
- Drive the selection, collaborations and oversight of CROs and external vendors to ensure efficiency, quality, and consistency for all DM deliverables
- Develop and maintain expert competencies within Data Management
- Ensure compliance with regulatory and industry process and quality standards
- Represent DM in regulatory inspections
- Collaborate with cross-functional leads to ensure team effectiveness
- Bachelor’s degree in the scientific/healthcare or related field; Master’s or Advanced degree preferred
- A minimum of 12 years (Director) to 15 years (Sr. Director) of professional DM experience in Pharmaceutical, Biotech, or CRO industry
- Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred
- Significant end-to-end, hands-on experience in all aspects of data management
- Significant experience working with clinical trials
- Significant experience and extensive knowledge of the complex and interdependent relationships between protocol development, data collection, data review, and cleaning activities, analysis and reporting
- Significant experience leading data management activities for clinical trials; expert knowledge of DM processes, tools, methodologies and documentation; expert understanding of DM strategy
- Significant experience with EDC platforms and database design, including Medidata Rave and Oracle Clinical Inform
- Significant experience of clinical DM outsourcing with full service global CROs and niche providers
- Knowledge of GCP, FDA, ICH, CDISC, CDASH regulations and guidelines
- Experience in resource and budget management
- Experience in regulatory inspections
- Excellent verbal and written communication skills