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Our client is currently seeking a Clinical Data Manager. Below is a BRIEF job description.
- Data Management operational support of sample collection, clinical validation and reproducibility studies
- Work within standardized DM processes, SOPs and documentation templates to generate key project DM deliverables (Data Management Plans, Data Transfer Plans, Database Specifications, etc.)
- Work with Electronic Data Capture tools and vendors and assist with development, design and testing of project Case Report Forms, DM workflows
- Develop in house data processing software, database loading, processing and reporting tables as well as design and execute software test cases for software validation exercises
- Effectively communicate and manage expectations with project teams and EDC tool vendors and handle timely change requests as needed
- Bachelor’s degree or above (Master's preferred) in a biomedical or computer science discipline
- Proficient in computer programming skills (Python, MS Visual Studio, other...) and database development environments (MySQL, SQL Server, other...)
- Strong communication and partnership skills with clinical site personnel, Clinical Research Associates, Biostatistics and external tool vendors
- Strong knowledge of medical and data management terminology
- Experienced and understands the practice of Software Development Life Cycle (SDLC) particularly in the validation and verification of software
- Experienced and understands the practice of Clinical Data essentials for trial management including CRF design and completion guidelines and development of processes and audit trails for handling data transfers
- At least 3 years of experience in data management in a clinical research environment. Experience in a lead role preferred
- At least 2 years of experience in software projects in a development role