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Clinical Data Manager in San Diego, CA at APEX Systems

Date Posted: 3/15/2019

Job Snapshot

Job Description

Job #:  914561

Duties:

  • Data Management operational support of sample collection, clinical validation and reproducibility studies at the company site.
  • 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 (CRFs), 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

 

Qualifications:

  • 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
  • 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

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178