Specialist, Clinical Data Management - Hybrid
About The Position
Responsible for the creation and execution of 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. This includes: Internet-based EDC, Electronic devices, Electronic diaries and COA/IVRS/IWRS. Reporting and documenting testing results thoroughly and accurately is required. Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications. Additionally, the individual may be responsible for writing standard and trial-specific test scripts and providing peer reviews of User Acceptance Testing documentation. All activities will be conducted in compliance with our Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Requirements
- B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.
- 2+ Years of System Development Lifecycle Management / system validation knowledge.
- Database design and development knowledge.
- An overall working knowledge of the clinical development process.
- Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
- Exceptional organizational and problem-solving skills.
- Ability to work cross functionally and as part of a team.
- Able to work under pressure and change environment with flexibility.
- System Development Lifecycle Management / system validation knowledge.
- Knowledge of Python, Java, C#, Jira, Power BI, Github, SQL.
- Clinical Data Management
- Data Analysis
- Database Development
- Data Processing
- Data Quality Assurance
- Data Validation
- Data Visualization
- Electronic Data Capture (EDC)
- Learning Agility
- PL/SQL (Programming Language)
Nice To Haves
- Knowledge of database structures and available tools to manage, extract, and report data is preferred.
- Collaboration
- Communication
- Teamwork
Responsibilities
- Creation and execution of 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.
- Reporting and documenting testing results thoroughly and accurately.
- Partnering with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications.
- Writing standard and trial-specific test scripts.
- Providing peer reviews of User Acceptance Testing documentation.
- Conducting all activities in compliance with Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
