Note: The job is a remote job and is open to candidates in USA. Perceptive Inc. is focused on shaping the future of clinical research, helping the biopharmaceutical industry bring advanced medical treatments to market faster. The Clinical Data Programmer I will create databases and exports for sponsor study setups, perform User Acceptance Testing, and develop data collection forms to enhance data acquisition efficiency.
Responsibilities
- Develop data collection forms to maximize efficiencies in data acquisition across multiple imaging modalities and therapeutic areas
- Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas
- Programming and testing data export programs in accordance with specific client needs
- Design and develop custom calculations, error checks, and automated data validation routines
- Build data conversion paths and develop efficient and appropriate sponsor deliverable file formats, including CDISC SDTM and ODM compliance requirements
- Advise on the development of database quality standards including the oversight of standard eCRF library and version control processes
- Assist with the development of data integrations for continuity across internal data platforms (sites, sponsors, perceptive locations)
- Provide coaching, support and mentoring to less experienced team members in data management practices and related technical issues
- Support Data Management personnel in the development of technical documentation
- Carry out any other reasonable duties as requested
Skills
- Strong documentation and reporting capabilities
- Strong written and verbal skills for effectively communicating with departmental staff and research centers
- Experience implementing CDISC standards
- Understanding of GxP
- Understanding of 21 CFR Part 11
- Entry level SAS programming experience
- Experience with EDC (e.g. OpenClinica, RAVE, Inform, TrialMaster, etc.)
- Entry level SQL proficiency
- Entry level Javascript proficiency
- Bachelor's Degree in mathematics, computer science or equivalent demonstrated technical and analytical experience
- Previous experience in data management role
Benefits
- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings
- 401(k) program, life & accident insurance and disability insurance
Company Overview
Expanding on their combined 50-year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing. It was founded in 1996, and is headquartered in London, England, GBR, with a workforce of 1001-5000 employees. Its website is https://www.perceptive.com.