CDM Lead: Clinical Data Management & Data Quality

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

Job summary

CRISPR Therapeutics, Inc. in Boston, MA is seeking an Associate Manager, Clinical Data Management to support data management across all stages of clinical drug development.

You will ensure data capture systems, processes, and documentation yield accurate, complete, and high-quality data, including data review, query management, and reconciliation. Collaborating with study teams and vendors, you will develop CDM documentation, oversee UAT, and contribute to SOPs and inspection readiness while

Qualifications

• Bachelor0s Degree in a health-related field.
• 4-6+ years of clinical data management experience at Sponsor, CRO, and/or Investigative site.
• 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.
• 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.

Responsibilities

• Plan, coordinate, and manage data management tasks and timelines.
• Collaborate with internal cross functional management to ensure all stakeholders7 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

Analytical skills

Communication

Multitasking

Team collaboration

GCP knowledge

Education

Bachelor7s Degree in a health-related field

Tools

Medidata Rave

Veeva

J-Review

BOXI

CDISC standards

CDASH/SDTM

Microsoft Word

Microsoft Project

PowerPoint

Job description

CRISPR Therapeutics, Inc. in Boston, MA is seeking an Associate Manager, Clinical Data Management to support data management across all stages of clinical drug development.

You will ensure data capture systems, processes, and documentation yield accurate, complete, and high-quality data, including data review, query management, and reconciliation. Collaborating with study teams and vendors, you will develop CDM documentation, oversee UAT, and contribute to SOPs and inspection readiness while