Clinical Database Developer

Overview:

Clinical Database Developer

US Remote

Emmes Group: Building a better future for us all.

Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

If you share our motivations and passion in research, come join us!

Primary Purpose

Proficient in creating SQL-based or configuration-based data validation checks and provides expertise for implementing CDISC standards such as CDASH and SDTM within the EDC system. This individual is a technical subject matter expert on clinical database development issues and may serve as a Product Owner or Scrum Master on the crossfunctional Agile team and serve in a leadership or consultant role for a therapeutic area or department.

Responsibilities:

• Designs and configures electronic case report forms (eCRFs), (e.g., metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations); consults with teams as expert in eCRF layout and clinical database design and has expertise in requirements writing; serves as department subject matter expert in design and configuration
• Provides expertise in configuration of complex protocols, visit schedules/folders and sites in relevant clinical data system builder or architect module and advises on best approaches and implementation
• Provides expertise in complex system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system; advises team to ensure streamlined system configuration and appropriate capability.
• Provides expertise in evaluating complex requirements, determines feasibility based on system capabilities, identifies and implements novel or unique solutions
• Performs complex eCRF and data system quality control, testing and verification activities with high degree of accuracy and consistency; may provide consultation to other teams within department
• Writes and executes test scripts for complex configurations
• Performs EDC releases (Test, Train and Production), depending on the EDC system; including CRO global library
• Implements/programs Data Validation Plans/Specifications; programs SQL-based or configuration-based data validation checks. Creates custom functions and procedures; reviews or performs manual data changes; may perform code review
• Provides expertise for implementation of CDISC standards such as CDASH and SDTM within the EDC system; may perform SDTM mapping using SQL or other language; supports development and maintenance of global standards within therapeutic area
• Implements complex Data Migration Plans (e.g., study data import/export, clone or transfer of previous study); configures or develops complex 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 contribute to review of department SOPs or work practices
• May administer system modules (e.g., reports, PDF services, batch uploader) or perform user or site administration across applications
• May serve as a Product Owner, Scrum Master, or Tester on the Agile team; participates in Agile cross-team coordination meetings to facilitate sharing of ideas and process improvements across teams
• Provides mentorship of senior team members and demonstrates technical leadership within a clinical data system or therapeutic area; participates in initiatives or committees relevant to system delivery team processes
• Provides technical support to internal users for complex issues; reports defects and follows through to resolution ensures proper escalation and notification to other impacted teams; may participate in review of system issue trends and corrective actions
• Other duties as assigned

Qualifications:

• 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 8 years of progressive clinical database development experience (or master’s degree with 6 years) and strong understanding of clinical research and clinical database development and Agile processes
• Experience with database structures and programming languages strongly preferred
• Experience with eCRF design and specifications development strongly preferred
• Experience writing, programming, or configuring data validation checks strongly 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 strongly preferred
• 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 strongly preferred
• Excellent oral and written communication skills
• Detail-oriented
• Skills in prioritization, organization, and time management
• Team player
• Self-motivated and proactive with demonstrated ability to work independently
• Ability to coordinate the work of others

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:

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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