Manager/AD of Clinical Data Programming
Reporting to the Head of Data Management, the Manager/AD of Clinical Data Programming will lead clinical data programming activities in support of CRISPR studies across all stages of clinical drug development. They will work with the CRO and external data vendors on SDTM specifications/output and data transfer guidelines and will be responsible for the validation of those deliverables. They will also support the production of output for internal data review and QC to ensure accurate, consistent, high quality, and complete data across our clinical trials. The candidate will impact multiple clinical development programs, health authority submissions, presentations and publications across internal and external stakeholders.
- Plan, coordinate, and manage data programming tasks and timelines
- Act as primary liaison for programming matters with CROs, third party data vendors, and EDC vendors
- Serve as subject matter expert on CDISC and SDTM
- Perform validation and QC/QA of CDISC, SDTM and SDTMIG outputs from CRO partner(s)
- Plan, coordinate, and maintain clinical data programming timelines
- Program output, create ad hoc reports for data management and study team review
- Review/approve edc database structure and annotated CRFs
- Participate in UAT of clinical databases
- Lead/Participate in the development of programming SOPs, work guidelines and data standards
- Participate in the selection and implementation of programming and clinical data management software and solutions.
- Bachelors or Master’s Degree in computer science or related field
- 5-10 years of SAS clinical data programming experience in a regulatory environment
- Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools
- Knowledge of, and experience designing EDC databases, including Oracle Inform
- Knowledge of, and experience with CDASH/SDTM/CDISC standards
- Experience programming edit checks both within data management systems as well as in SAS
- Knowledge of current technical trends in the industry as they relate to data systems and programming
- Ability to apply innovative technical solutions to support our trials
- 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 and programming
- 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
- Programming in Spotfire and/or other data visualization tool(s)
- 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.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.