Clinical Database Developer

Clinical Database Developer

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Clinical Database Developer (CDD) is responsible for delivering high-quality electronic data capture (EDC) platform and clinical database study configurations. CDDs work as an integral part of an agile team and may perform or consult on activities such as user acceptance testing (UAT) of EDC systems, data integration, upload, or transfer development, and global library/standards development. Supports creation of SQL-based or configuration-based data validation checks and/or implement CDISC standards such as CDASH and SDTM within the EDC system.

• Designs and configures electronic case report forms (eCRFs), (e.g., metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations)
• Configures protocol, visit schedules/folders and sites in relevant clinical data system builder or architect module
• Configures system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system
• Evaluates requirements and determines feasibility based on system capabilities
• Performs eCRF and data system quality control, testing and verification activities
• Writes and executes test scripts for routine configurations
• Performs EDC releases (Test, Train and Production), depending on the EDC system
• Implements/programs Data Validation Plans/Specifications; supports creation of SQL-based or configuration-based data validation checks; may review or perform manual data changes
• Implements CDISC standards such as CDASH and SDTM within the EDC system; familiar with mapping conventions and may perform eCRF annotations
• Implements Data Migration Plans (e.g., study data import/export, clone or transfer of previous study); may configure or assist with development of data integration, upload, or transfer
• Ensure compliance with industry quality standards, regulations, guidelines and procedures including applicable Federal Regulations and ICH/GCP
• Utilizes tracking system to document configuration and testing activities, maintain version control on all required configuration specifications, validation, and quality control documents as required by SOP
• May administer system modules (e.g., reports, PDF services, batch uploader) or perform user or site administration
• Actively participates as an Agile team member in all meetings; may serve as a backup to a Product Owner, Scrum Master, or Tester on the Agile team
• May mentor new team members
• Provides technical support to internal users for routine issues; reports defects
• Other duties as assigned

* Bachelor's degree in an analytic, technical, programming, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree

* Incumbent typically will possess at least 2 years of experience (or Master's degree) and basic understanding of clinical database development and Agile processes

* Experience with database structures and programming languages preferred

* Experience with eCRF design and specifications development preferred

* Experience writing, programming, or configuring data validation checks preferred

* Experience with QC, UAT, platform testing, and writing and executing test scripts preferred

* Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and CDISC standards (CDASH, SDTM) preferred

* Knowledge of software development lifecycle activities; experience with Agile/Scrum a plus

* Strong computer skills; experience with eCRF design, clinical databases, EDC systems (e.g., Medidata Rave, Oracle Clinical, REDCap), or other web-based data collection systems helpful

* Excellent oral and written communication skills

* Detail-oriented

* Skills in prioritization, organization, and time management

* Team player

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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