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Associate Director/Director, Data Management

If interested and qualified, please include Requisition # 2018-325 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

This position reports to the Head of Clinical Operations.

The Associate Director/Director will lead data management activities in support of CRISPR studies across all stages of clinical drug development. This includes functional execution in addition to strategic planning for scalability. He/she 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: 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.

This position will serve as the in-house Data Management expert and provide consultation to all functions within CRISPR Therapeutics as necessary. The Data Manager will help to recruit and hire a small data management team.

Responsibilities

  • Plan, coordinate, and manage data management tasks and clinical study 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/reviewer for CRFs/eCRFs, CCGs/eCCGs, and Data Management Plans
  • Oversee database design and production, ensuring that the CRO meets the highest quality standards
  • Oversee report specification development including patient profiles and TLFs supporting clinical development decisions, periodic regulatory filings and study oversight
  • Accountable for external data vendor documentation, management, and reconciliation
  • Contribute to departmental process improvement and integration of technology
  • Perform and/or review Coding and SAE reconciliation
  • Experience developing reports using SAS
  • Support GCP inspection readiness

Minimum Qualifications

  • Bachelor’s or Master’s Degree in a health-related field
  • Minimum of 8 years of clinical data management experience in a regulatory environment
  • Demonstrated proficiency managing the lifecycle of clinical data projects
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
  • Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management
  • Ability 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

Preferred Qualifications

  • 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

Competencies

  • Adaptability/Flexibility - The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
  • Communication and Teamwork - The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Leverage Systems & Technology - Uses systems and technology in a facile way. Identifies opportunities to improve processes through systems and technology.
  • Results-Oriented - Drives issues to closure and gets the job done.
  • Risk and Compliance Management - Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies.

If interested and qualified, please include Requisition # 2018-325 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.