CDM Associate Manager: Data Quality & Systems

CRISPR Therapeutics; Boston (MA); Hybrid; USD 100,000 - 115,000; Full time

Job summary

CRISPR Therapeutics is seeking an Associate Manager of Clinical Data Management to support data management activities across all stages of clinical drug development. You will work with cross-functional teams to ensure accurate, complete data, handling data review, queries, reconciliation, and vendor data.

The role also covers documentation, UAT, and GCP inspection readiness. The position requires 4–6+ years of CDM experience, familiarity with Medidata Rave, Veeva, and CDISC standards, plus

Qualifications

• Bachelor’s Degree in a health‑related field.
• 4–6+ years of clinical data management experience.
• Knowledge and experience with Microsoft applications including Word, MS Project, PowerPoint.
• Knowledge and experience with major EDC databases including Medidata Rave, Veeva, etc.
• Experience developing reports using J‑Review, BOXI, and/or other CDM reporting tools, including data visualization software.
• Knowledge of CDASH/SDTM/CDISC standards.
• Experience working with central and specialty labs/vendors.
• Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHODrug.
• 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.

Responsibilities

• Plan, coordinate, and manage data management tasks and timelines.
• Collaborate with internal cross functional management to ensure all stakeholders’ needs are addressed.
• Lead the development of data management documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third‑party vendor data specifications; Coordinate related reviews with cross functional team(s).
• Ensure proper filing and documentation of clinical data management documents.
• Lead and participate in UAT of clinical data management systems.
• Lead and participate in clinical data review and data reconciliation.
• Prepare content and participate in study team meetings.
• Contribute to departmental SOP and process development/improvement and integration of technology.
• Support GCP inspection readiness.

Skills

CDM experience

EDC systems

Data reconciliation

UAT testing

Vendor management

Data querying

CDISC/SDTM/CDASH

Medidata Rave

Veeva

J-Review / reporting tools

Education

Bachelor’s Degree in a health-related field

Tools

Medidata Rave

Veeva

J-Review

Job description

CRISPR Therapeutics is seeking an Associate Manager of Clinical Data Management to support data management activities across all stages of clinical drug development. You will work with cross-functional teams to ensure accurate, complete data, handling data review, queries, reconciliation, and vendor data.

The role also covers documentation, UAT, and GCP inspection readiness. The position requires 4–6+ years of CDM experience, familiarity with Medidata Rave, Veeva, and CDISC standards, plus