MMS Holdings Inc. is a growing clinical research organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. Our strong industry experience and scientific approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. Our clients span from top 10 pharma to virtual biotechs, and we support each one with the same standard of excellence. Our core service areas include medical and regulatory writing, biostatistics, clinical programming, data management, clinical development, clinical trial disclosure, regulatory affairs, regulatory submissions and pharmacovigilance.
Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patient’s lives worldwide.
This is a project-based consulting role. Remote/ home-office can be considered.
- 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 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 Relational Database Management Systems (RDBMS) (including Oracle InForm)
- 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