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Clinical Data Manager in Del Mar, CA at Vaco

Date Posted: 1/10/2019

Job Snapshot

Job Description

Clinical Data Manager

Primary responsibilities:

* 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

Skills and Qualifications:

* Bachelor's degree or above (Master's preferred) in a biomedical or computer science discipline

* Proficient in computer skills for communication and reporting (word processing, spreadsheets, presentations and flowcharts)

* 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

Experience:

* 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