Lead Clinical Database Testing Analyst
hace 7 días
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 documentation10% 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 appropriate10% May be assigned to lead or participate in cross-functional technical and/or process improvement projects5% As SME, the person may participate in the development of job-specific training material, with MPI, and deliver training material as needed to the staff5% May be assigned to a lead role for larger, more complex, or higher risk clinical trial programs to ensure consistency across teamsRequirements Education: B.A.
or B.S.
degree, preferably in mathematics, science, a health care related discipline, or computer science.
Knowledge and Skills: 4+ years System Development Lifecycle Management/system validation knowledgeDatabase design and development knowledgeAn overall working knowledge of the clinical development processKnowledge of database structures and available tools to manage, extract, and report data is preferredExceptional communication skills (oral and written) with the ability to communicate with both the technical and business areasExceptional organizational and problem-solving skillsAbility to work cross-functionally and as part of a teamAble to work under pressure and change environment with flexibilityEmployee 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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