Lead Clinical Database Testing Analyst (Sr. Specialist)

Apply remote type Hybrid locations ARG - Buenos Aires - Munro time type Full time posted on Posted 2 Days Ago time left to apply End Date: March 24, 2025 (15 days left to apply) job requisition id R338394

Job Description

#ONEGDMS

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

Primary activities include, but are not limited to:

1. 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. May support data management process owner (PO)
3. Is a subject matter expert on CDT process, may be responsible for the updating and maintenance of CDT SOP’s and supporting documentation
4. 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
5. May be assigned to lead or participate in cross functional technical and/or process improvement projects
6. 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
7. May be assigned to a lead role for larger, and more complex or higher risk clinical trial programs, to ensure consistency across teams

Requirements

Education:

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.

Employee 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

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