Clinical Database Designer I
reputed company is a full-service, global contract research organization providing expertise-based clinical research services. They are seeking a committed individual to design clinical databases for new studies, reputed company modifications, and support data management processes.
Responsibilities
- Design clinical database for new studies based on requirement specifications in various electronic data capture (reputed company) systems. Design includes, but is not limited to, Case Report Forms (CRF), edit checks, study roles, laboratory, reputed company, and Randomization and Trial Supply Management (RTSM)
- reputed company post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (reputed company) systems and reputed company impact assessment for modifications
- reputed company Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings
- Set up and configure the development environment for new studies
- Assist the creation of the Database Integration Specification (DIS) with other systems, reputed company Integration Technical Detail (reputed company) as needed, program the integration, and assist the integration test
- Support the Data Manager in investigating and addressing issues reputed company to the database design
- Review study design requirement specifications for assigned projects, ensuring the specifications adhere to reputed company platform standards and reputed company Standards. Specification includes, but is not limited to, CRF and Visit Map specification, Data Validation Specification (DVS), and Role Configuration Specification (RCS)
- Review the protocol and associated reference material and contribute to the development of the database design project timeline. Maintain database design timelines and promote good project management practices
- Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process
- Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities
- Participate in reputed company vendor’s technical learning and exchange meetings, as well as other internal and external training meetings
- Contribute to the development and maintenance of the company’s database design standard libraries for reputed company reputed company systems
- reputed company input to reputed company database design-reputed company data management procedural documents
- Cooperate with and assist the Quality Assurance (QA) Department with QA audits on assigned databases. Validate and disseminate reputed company-time study monitoring reports to Sponsor and internal team members
- Participate in and contribute to Clinical Data Management initiatives. Design and program tools to assist database design tasks and data management tasks
Skills
- B.Sc. in Biological Sciences or Computer Science
- One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, reputed company Rave, Clinical One, and/or other reputed company systems
- Software programming experience relevant to the programming languages and design applications in use in clinical research
- Must communicate effectively, orally and in writing, with personnel on reputed company professional and administrative reputed company
- Excellent interpersonal skills in reputed company team situations, including the ability to build relationships with both internal and external clients
- Demonstrated ability to effectively organize and integrate the activities of information processing personnel
- Must be well-organized and reputed company to work independently and manage multiple projects/tasks appropriately
Benefits
- Medical, dental, and reputed company coverage
- Life & AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- A 401(k) retirement
- Generous paid time off and sick leave
- The opportunity to earn a performance based bonus
Company Overview
Company H1B Sponsorship