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Replacement req for 4554308.
The Clinical Data Associate Principal position requires a highly skilled individual, who seeks a technical rather than a managerial career path. Will often be responsible and play a key role in the development, implementation and maintenance of web-based data collection and reporting tools for observational rare disease registries in support of scientific, clinical, regulatory and commercial goals.
Investigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management.
Work with the Global Medical Director and project team in designing and developing Case Report Forms (CRFs).
Create the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
Good working knowledge of CDISC-SDTM, ODM, CDASH guidelines.
Develop and maintains X-Registry eCRF library and validation checks.
Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing. Lead and assign user accepting testing to data management peers and oversee the completion of the testing.
Execute assigned QC/QA procedures to ensure that clinical databases meet corporate and regulatory standards with accuracy and completeness.
Perform activities related to the implementation, development, maintenance and training of the existing system, e.g. gathering system change requests, incorporating recommendations from users and contributing to system enhancements.
Collaborate with a highly motivated and experienced data management team on process improvement and implementation of new technology.
Participate in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines.
Collaborate with data management peers and other functional departments to define and develop operational type reports to assist with data exploration and metrics for management team.
Develop training materials and provide training on technical applications to data management peers and Site Operations personnel.
Create and manage data management workflow documentation, to include, but not limited to; Data Review Guidelines, eCRF Completion Instructions, Data Validation Plan and Data Management Plan.
Work together with technical vendors and data management team to troubleshoot database bugs/issues from root cause to resolution. Requires analytical and problem-solving skills, with good attention to detail.
Responsible for tracking individual project tasks and overall project timelines.
Review and approve technical vendor contracts, change orders and invoices.
4-6 years of experience in developing database and validation requirements/specifications
6-8 years of experience with Electronic Data Capture (EDC)
2-4 years of experience with Reporting Tools (e.g., BOXI, SAS, Business Objects)
2-4 years of experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines
Education:Bachelor’s degree in related science/technical discipline required or a minimum of 9 years of data management experience in the Pharmaceutical/Biotechnology industry
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