12 mar
Msd
Vicente López
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:
- 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.)
- 10% May support data management process owner (PO)
- 15% Is a subject matter expert on CDT process, may be responsible for the updating and maintenance of CDT SOPs and supporting documentation
- 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
- 10% May be assigned to lead or participate in cross-functional technical and/or process improvement projects
- 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
- 5% May be assigned to a lead role for larger, 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
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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