Study Data Manager

Santa Clara Valley (Cupertino), California, United States
Hardware

Summary

Posted: Aug 29, 2019
Weekly Hours: 40
Role Number: 200044732
The Health Technologies Team conceives and proves out exciting new technology for Apple’s future products and features. We are seeking a Study Data Manager to serve as a technical lead for all data management activities for health related studies.

Key Qualifications

  • 5+ years of clinical data management experience
  • Detailed oriented, thorough, and organized
  • Strong track record of on-time project delivery
  • Experience with Electronic Data Capture systems
  • Experience working with external test sites and/or managing vendors
  • Ability to influence teams to adopt best practices
  • Self-motivated and proactive with critical thinking and resourcefulness to drive the project to success
  • Excellent communication skills, both verbal and written
  • Ability to work independently as well as in a collaborative environment
  • Experience working in a regulated environment.
  • An expert understanding of relevant global regulatory requirements pertaining to data management, electronic records, etc. is a plus
  • Some travel may be required
  • Human clinical research background good to have but not a must

Description

A Study Data Manager is responsible for providing oversight and direction of data management activities for all studies. Managing the entire data lifecycle of a study specifying data requirements, processes required, acceptance criteria, and data integrity inspection. Developing and/or reviewing database design specifications, edit checks, and case report forms based on study specification. Building out studies in the EDC system. Creating entry and data handling guideline documents for site data entry. Working with Algorithm developers, clinicians, and statisticians to ensure the right data is being collected for the study. Designing complete data management quality plan and offering solutions to address quality concerns. Working with external vendors to set database specifications, data types, and data acceptance criteria. Developing and maintaining data management related standard operating procedures as appropriate. Providing requirements for data tools. Collaborating with team members and vendors to support the study set-up, maintenance, and project closeout of data management activities

Education & Experience

Additional Requirements

  • B.S., MS., or equivalent in biological sciences, Computer Science or any engineering discipline