Manager of Data Management
Reporting to the Head of Data Management, the Manager of Clinical Data Management will lead data management activities in support of CRISPR Therapeutics studies across all stages of clinical drug development. They will ensure that clinical data capture, systems, and processes will ensure accurate, consistent, high quality, and complete data.
The candidate will provide clinical data management oversight of outsourced clinical trials including but not limited to: project management, vendor management, coordination of internal reviews, and approval of deliverables. The candidate will impact multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
- Plan, coordinate, and manage data management tasks and timelines
- Act as primary liaison with CROs, third party data vendors, and EDC vendors
- Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed
- 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, ensuring that the CRO meets the highest quality standards
- Accountable for external data vendor documentation, management, and reconciliation
- Contribute to departmental SOP and process development and improvement, and integration of technology
- Perform and/or review medical coding and SAE reconciliation
- Support internal review/QC of clinical data
- Support GCP inspection readiness
- Bachelors or Master’s Degree in a health-related field
- Minimum of 5 years of clinical data management experience in a regulatory environment
- Demonstrated proficiency managing the lifecycle of clinical data projects
- Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools
- Knowledge of, and experience with EDC databases including Oracle Inform
- Knowledge of, and experience with CDASH/SDTM/CDISC standards
- Experience working with central and specialty labs/vendors
- Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO
- Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management
- Able to manage multiple initiatives and shifting priorities within a small company environment
- Strong analytical and problem-solving skills that meet or improve the status quo
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
- Excellent written and oral communication skills
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- SAS programming experience
- Experience with global studies, using an outsourced CRO model
- Experience in clinical drug development including first-in-human through registration trials
- NDA, BLA, MAA experience
- Experience with drug development in rare genetic diseases and oncology
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-384 in the subject line when emailing resume to: firstname.lastname@example.org.
For more information on CRISPR Therapeutics, please click here.