Lead Clinical Database Testing Analyst

hace 2 semanas


Partido de Vicente López, Argentina JPMorganChase A tiempo completo
Lead Clinical Database Testing Analyst (Sr. Specialist)

MSD

Position Overview

Under the direction of the Director/Associate Director, the Lead CDT Analyst creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes internet-based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc., along with reporting and documenting testing results. Additionally, the individual may be responsible for writing standard and trial-specific test scripts, as well as providing peer review of CDT documentation. All in compliance with our Company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary Activities
  1. 45% Same responsibilities as the CDT Analyst II (Responsible for the creation/modification/execution of standard and trial-specific test scripts and record test data and test results. Responsible for the creation of Test Plans and Test Summary documentation. Responsible for the facilitation and coordination of testing activities related to the tool/system being tested. Responsible for the triaging and categorization of issues identified during UAT. Based on his/her experience, be able to support any role or task into the team when needed.)
  2. 10% may support data management process owner (PO)
  3. 10% should continually monitor the process looking for opportunities to improve the current process; to improve efficiency and effectiveness of the CDT group, additionally the person should implement changes as appropriate
  4. 10% May be assigned to lead or participate in cross-functional technical and/or process improvement projects
  5. 5% As SME the person may participate in the development of job-specific training material, with MPI, and deliver training material as needed to the staff
  6. 5% may be assigned to a lead role for larger, and more complex or higher risk clinical trial programs, to ensure consistency across teams
RequirementsEducation

B.A. or B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.

Knowledge and Skills
  1. 4+ years System Development Lifecycle Management / system validation knowledge
  2. Database design and development knowledge.
  3. An overall working knowledge of the clinical development process.
  4. Knowledge of database structures and available tools to manage, extract, and report data is preferred.
  5. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
  6. Exceptional organizational and problem-solving skills.
  7. Ability to work cross-functionally and as part of a team.
  8. Able to work under pressure and change environment with flexibility.
Search Firm Representatives Please Read CarefullyEmployee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

03/24/2025

Requisition ID

R338394

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