The Clinical Data Associate III position is part of the Data Management Technical Team, which is a sub-group of the overall Registry Data Management group. This position is a technical individual dedicated to operational activities related to the technical development, implementation, and maintenance of Client's Global Rare Disease Registry web-based electronic data capture (EDC) and reporting technology platform.
Collaborate with the project team to help gather technical requirements for the Rare Disease Registry web-based EDC and reporting technology platform.
Create and maintain the following documents for the Rare Disease Registry web-based EDC and reporting technology platform: eCRF database specifications, data validation (edit checks) specifications, report specifications, and other functional specifications.
Create User Acceptance Test (UAT) Plans, write systematic and detailed UAT test scripts, and execute testing.
Provide peer review/QC of technical specifications/documentation to ensure consistency and accuracy.
Collaborate with the technical vendor on EDC database changes and ensuring requirements are implemented correctly.
Collaborate with the technical vendor and data management team to troubleshoot database bugs/issues from root cause to resolution.
Develops training materials and provides training on technical applications to data management peers and Site Operations personnel.
Collaborates with the Data Management team to define and develop operational reports to assist with data exploration and metrics.
Collaborates with the Data Management team in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines.
Clinical data management experience (CRF design, data collection, data review, query management)
Experience with EDC systems
Clinical database experience including eCRF/database design and development, system edit check design and development, writing UAT scripts, and conducting UAT
Good working knowledge of software development life cycle (SDLC) and change management
Good working knowledge of industry data standards (e.g., CDASH, SDTM) and how to apply them to CRF design and database development
Ability to work with reporting/analytical tools (e.g., Business Objects) to manipulate data and produce metrics
Strong organizational skills and attention to detail
Strong team work and collaboration skills
Strong communication skills (verbal and written)
Experience with training and developing training materials
Good working knowledge of International Regulations / Guidelines / Good Clinical Practices pertaining to the pharmaceutical industry standards and practices
At least 4 years of clinical data management/database development experience in the pharmaceutical/biotechnology industry.
At least 2 years of experience with EDC systems, preferably Medidata Rave.
At least 2 years of experience with EDC requirements, database development, user acceptance testing, and implementation of eCRF study builds
Experience with CRF migrations within EDC systems desired
Experience with validation of computer systems desired
Source: Job Diva – Job Listing