Manager, Clinical Data Management
CRISPR Therapeutics
4 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Position Summary
The Manager of Clinical Data Management will lead clinical data management activities in support of CRISPR studies across all stages of clinical development, ensuring accurate, consistent, high-quality, and complete data.
Responsibilities
- Plan, coordinate, and manage data management tasks and timelines.
- Serve as primary liaison with CROs, third-party data vendors, and EDC vendors.
- Collaborate with internal clinical study teams to address stakeholder needs.
- Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, coding plans, data management plans, and third-party vendor data specifications.
- Oversee database design, production, and UAT cycles to ensure CRO quality standards.
- Accountable for external data vendor documentation, management, and reconciliation.
- Contribute to departmental SOP/process development, improvement, and technology integration.
- Perform and/or review medical coding and SAE reconciliation.
- Support internal review/QC of clinical data.
- Support GCP inspection readiness.
Minimum Qualifications
- Bachelor’s degree in a health-related field (Master’s degree strongly preferred).
- 7+ years of progressive clinical data management experience in a regulatory environment.
- Demonstrated proficiency managing the lifecycle of clinical data projects.
- Experience developing reports using J-Review, Business Objects, or other CDM reporting tools.
- EDC database experience (especially Medidata Rave).
- CDASH/SDTM/CDISC standards experience.
- Experience working with central and specialty labs/vendors.
- Working knowledge of medical terminology and coding dictionaries (MedDRA, WHO).
- Familiarity with GCP, ICH, and FDA requirements as applicable.
- Ability to manage multiple initiatives and shifting priorities in a fast-paced environment.
- Strong analytical and problem-solving skills.
- Excellent interpersonal, independent and collaborative work skills.
- Excellent written and oral communication skills.
Preferred Qualifications
- Prior experience in a small or medium-sized biotech or pharmaceutical company.
The Manager of Clinical Data Management will lead clinical data management activities in support of CRISPR studies across all stages of clinical development, ensuring accurate, consistent, high-quality, and complete data.
Responsibilities
- Plan, coordinate, and manage data management tasks and timelines.
- Serve as primary liaison with CROs, third-party data vendors, and EDC vendors.
- Collaborate with internal clinical study teams to address stakeholder needs.
- Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, coding plans, data management plans, and third-party vendor data specifications.
- Oversee database design, production, and UAT cycles to ensure CRO quality standards.
- Accountable for external data vendor documentation, management, and reconciliation.
- Contribute to departmental SOP/process development, improvement, and technology integration.
- Perform and/or review medical coding and SAE reconciliation.
- Support internal review/QC of clinical data.
- Support GCP inspection readiness.
Minimum Qualifications
- Bachelor’s degree in a health-related field (Master’s degree strongly preferred).
- 7+ years of progressive clinical data management experience in a regulatory environment.
- Demonstrated proficiency managing the lifecycle of clinical data projects.
- Experience developing reports using J-Review, Business Objects, or other CDM reporting tools.
- EDC database experience (especially Medidata Rave).
- CDASH/SDTM/CDISC standards experience.
- Experience working with central and specialty labs/vendors.
- Working knowledge of medical terminology and coding dictionaries (MedDRA, WHO).
- Familiarity with GCP, ICH, and FDA requirements as applicable.
- Ability to manage multiple initiatives and shifting priorities in a fast-paced environment.
- Strong analytical and problem-solving skills.
- Excellent interpersonal, independent and collaborative work skills.
- Excellent written and oral communication skills.
Preferred Qualifications
- Prior experience in a small or medium-sized biotech or pharmaceutical company.