Specialist, Clinical Data Management - Hybrid

Merck•Rahway, NJ

1d•$87,300 - $137,400•Hybrid

About The Position

The Specialist, Clinical Data Management is responsible for creating and executing Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture systems, in-life data review reports, and clinical data management databases. Systems and tools include internet-based EDC, electronic devices, electronic diaries, and COA/IVRS/IWRS. The role requires thorough and accurate reporting and documentation of test results. The specialist partners with functional area representatives to ensure database standards and project-level consistency across database, data collection, review, and retrieval specifications. The individual may also write standard and trial-specific test scripts and peer review UAT documentation. All activities are conducted in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Requirements

Bachelor of Science degree, preferably in mathematics, science, a healthcare-related discipline, or computer science.
At least 2 years of System Development Lifecycle Management and/or system validation knowledge.
Knowledge of database design and development.
Overall working knowledge of the clinical development process.
Exceptional oral and written communication skills, with the ability to communicate with technical and business areas.
Exceptional organizational and problem-solving skills.
Ability to work cross-functionally and as part of a team.
Ability to work under pressure and adapt flexibly to a changing environment.
Knowledge of Python, Java, C#, Jira, Power BI, Github, and SQL.
Required skills include Clinical Data Management, Data Analysis, Database Development, Data Processing, Data Quality Assurance, Data Validation, Data Visualization, Electronic Data Capture (EDC), Learning Agility, and PL/SQL.

Nice To Haves

Knowledge of database structures and available tools to manage, extract, and report data.
Preferred skills include Collaboration, Communication, and Teamwork.

Responsibilities

Create and execute QC testing and UAT procedures for electronic data capture systems, in-life data review reports, and clinical data management databases.
Report and document testing results thoroughly and accurately.
Partner with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications.
Write standard and trial-specific test scripts, as needed.
Provide peer reviews of UAT documentation, as needed.
Conduct activities in compliance with company SOPs and ICH-GCP guidelines.