Clinical Database Designer I

Everest Clinical Research; Bridgewater (MA); Hybrid; USD 50,000 - 90,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) retirement plan

Generous paid time off

Tuition reimbursement

Job summary

Everest Clinical Research in Bridgewater is looking for a Clinical Database Designer to develop databases for various clinical studies. Responsibilities include designing and modifying clinical databases, performing testing, and assisting with regulatory requirements.

The ideal candidate will have a B.Sc. in Biological Sciences or Computer Science and at least one year of relevant experience, particularly with EDC systems.

We offer a comprehensive benefits package and a competitive salary range of $50,000 - $90,000.

Qualifications

• One year of clinical database design experience.
• Experience in developing clinical databases in EDC systems.
• Must communicate effectively and work independently.

Responsibilities

• Design clinical databases based on specifications.
• Perform testing and quality assurance on database design.
• Maintain database design timelines and project management.

Skills

Clinical database design

Software programming

Interpersonal skills

Communication

Education

B.Sc. in Biological Sciences or Computer Science

Tools

DFdiscover

InForm

Medidata Rave

Clinical One

Job description

Clinical Database Designer

Location: Bridgewater, New Jersey, USA (on-site) or remote from any home-based office in the USA or Canada in accordance with our Work from Home policy.

Key Accountabilities

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems. Design includes, but is not limited to, Case Report Forms (CRF), edit checks, study roles, laboratory, coder, and Randomization and Trial Supply Management (RTSM).
• Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems and provide impact assessment for modifications.
• Perform 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, provide Integration Technical Detail (ITD) as needed, program the integration, and assist the integration test.
• Support the Data Manager in investigating and addressing issues related to the database design.
• Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest 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 EDC 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 all EDC systems.
• Provide input to all database design-related data management procedural documents.
• Cooperate with and assist the Quality Assurance (QA) Department with QA audits on assigned databases. Validate and disseminate real-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.

Qualifications and Experience

• B.Sc. in Biological Sciences or Computer Science.
• One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC 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 all professional and administrative levels. Excellent interpersonal skills in complex 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 able to work independently and manage multiple projects/tasks appropriately.

Benefits & Compensation

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision 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, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $50,000 - $90,000.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.