Clinical Database Designer I

Everest Clinical Research is a full-service global contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Clinical Database Designer I to design and manage clinical databases, perform testing, and support data management processes.

Responsibilities

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

Benefits

Medical, dental, and vision coverage

Life & AD&D insurance

Short- and long-term disability

Tuition reimbursement

Fitness reimbursement

Employee assistance program (EAP)

Pension plan

Generous paid time off and sick leave

Opportunity to earn a performance based bonus

Company

Full-service contract research organization for pharma, biotech, and medical devices

Toronto, Ontario, CAN

https://www.ecrscorp.com/

Founded in 2004

501-1000 employees

Qualifications

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

One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC systems.

Required skills

Clinical database design, DFdiscover, InForm, Medidata Rave, Clinical One, Electronic Data Capture (EDC) systems, Case Report Forms (CRF) design, Edit checks programming, Randomization and Trial Supply Management (RTSM), Database integration, Unit Testing, User Acceptance Testing (UAT), Data Validation Specification (DVS), Role Configuration Specification (RCS), Software programming

Experience

1+ years