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Clinical Data Associate IV
Ref No.: 17-15840
Location: Cambridge, Massachusetts
Role: Clinical Data Associate IV
Location: Cambridge, MA
Duration: 2+ Years

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.

Job Responsibilities:
  • 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 the technical vendor on study build changes and ensuring requirements are implemented correctly.
  • 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.

Basic Qualifications:
  • 4-6 years of experience in developing database and validation requirements/specifications
  • 6-8 years of experience with Electronic Data Capture (EDC), especially using Medidata Rave
  • 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

  • Bachelor's degree in related science/technical discipline required or a minimum of 9 years of data management experience in the Pharmaceutical/Biotechnology industry.