Providing Project Management guidance to study teams, study startup and closeout guidance, migration support, tracking high-level study milestone information and clinical view refreshes when required in the EDC. In his/her area of responsibility, responsible to support continuous improvement framework with respect to systems deployment, project management and enhancements supported by greater partnerships with suppliers, CRO partners and industry user groups. Will have the ability to contribute to a high functioning diverse team to enable industry-leading electronic data flow. He/she will have technical expertise and significant experience gained through working with diverse and complex business processes and associated system infrastructures. May be responsible for support in systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections.
Responsible for the following as well as other ad-hoc tasks.
1. Supporting study teams with scheduling migrations
2. Maintaining the Trial Data Repository in Medidata Rave
3. Database lock activities such as updating user access, clinical view (CV) refreshes
4. Database un-lock activities
5. Database archival activities such as removing all user access and turning off clinical views.
6. Uploading eCRF guidelines on the FTP server.
7. Granting user access to iMedidata and Medidata Rave
8. Submitting FTP requests for end users
9. Study Team support (internal and external partners) at a platform level for all therapeutic areas by answering ad-hoc questions.
10. Guide study team members to Data Collection Solutions documentation
11. Review listings and follow-up with study team members as appropriate
12. May have the responsibility to train or mentor new members in the organization.
13. Participate in UAT activities of system upgrades
14. Participate in cross sector initiatives as assigned
15. Assist with vendor management
16. Excellent problem solving and decision-making skills
17. Strong planning, organization and project management skills
18. Contribute to the Data Collection Solutions team active in the development, implementation, maintenance and continuous improvement of systems supporting end-to-end processes.
19. Other tasks as needed
Education and Experience Requirements/Qualifications:
20. Bachelors degree in Engineering, Science, or Computer Science is preferred.
21. Minimum of 3 years of experience working within systems covering clinical development in the Pharma sector.
22. Experience in DM lifecycle (start up - close out)
23. Standards and libraries experience
24. Knowledge of Electronic Data Capture (EDC) systems with strong working knowledge of iMedidata and Rave
25. Understanding of GCP, ICH, and 21 CFR part 11
This role is not eligible for UK visa sponsorship
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