MMS jobs - Clinical Database Developer

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards.

This could be a full-time or project-based consulting role.

Job Description

• Responsible for the design, development, and improvement of the clinical database
• Design databases that meet all requirements for entry and reporting of clinical data; maintain the integrity and quality of databases; control system capacity for existing requirements and plan for future needs; and test new processes and systems
• Maintain standard database dictionaries for dataset set-up; ensures documentation of procedures, source code (if applicable),and change control for Good Clinical Practice (GCP) validation within a test and production environment; programs data edit checks; implements tested applications to production environment once validation is complete; reviews case report forms for database standardization
• Develop screens, validation checks, back-end programming, and listings during database development and will coordinate the testing (UAT) of the database prior to release into production and the subsequent release to production once approved
• Excellent written, verbal, and organization skills
• Ability to lead and work with global teams
• Must also have knowledge of FDA requirements for data management systems and system validation
  
  

Minimum Requirements

• Minimum Education: BS or equivalent foreign degree in Computer Science, Computer Information Systems, or a related field
• Minimum Work Requirements: 3-5 years of clinical and/or research experience
• 1 year of Pharma, biotech or CRO experience or at least 2 years experience in a healthcare-related industry, or equivalent
• Qualified candidates will have at least 3 years of experience with Oracle Central Designer
• Working knowledge of Good Clinical Practice (GCP) and 21 CRF Part 11 are required.
• Advanced proficiency in computer skills (Microsoft Word, Excel, etc.)
• Motivated to work in a fast-paced environment. Capable of handling multiple tasks and have the ability to establish priorities and meet tight deadlines
• English language proficiency is a must