Senior Database Developer (Medidata Rave EDC)

Job responsibilities:

• Coordinate and perform Rave EDC programming activities and various programming deliverables within the data management group for assigned projects.
• Adherence to SOPs and maintaining audit-ready documentation.
• Coordinate and oversee activities of programming activities ensuring high quality, respecting project timelines and adherence to the budget.
• Provide technical support for clinical data management projects across multiple therapeutic areas.
• Work closely with clinical data management to ensure data quality.
• Act as a liaison with the clinical data management team on system change requests to current study database to understand potential issues and technical impacts.
• Coach and mentor other Database Developers in all areas of database developments
• Facilitate process improvements for EDC systems.
• Contribute to departmental procedures and guidelines.
• Coordinate and develop screens, appendix, edit checks and custom function programming during database development
• Perform test and prod migrations for Rave studies
• Perform quality control measures on deliverables.
• Communicate with all levels of internal team members and sponsors.
• Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks.

General requirements:

• Bachelor’s degree in Life Sciences, Computer Science or related discipline.
• A minimum of 6 years of progressive hands-on experience in Clinical Data Management or Clinical Research.
• Expert in Medidata Rave EDC database development including custom function programming
• Strong experience with test and production migrations
• Knowledge and experience of other Rave optional modules preferred
• Experience with other EDC systems and/or programming languages such as Python, R, SAS desirable.
• Strong knowledge of the pharmaceutical industry including understanding of clinical
  drug development process and associated documents (SOPs/Guidelines/Work Instructions).
• Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11.
• Working knowledge of CDISC standards for data management.
• Proficient with Microsoft office suite (Excel, Word, PowerPoint).
• Excellent verbal and written communication.
• Flexible and proactive with an ability to work independently and in a team environment.
• Detail-oriented with an analytical mind-set.
• Excellent problem-solving skills.