Overview:
Senior Clinical Database Developer
India Remote/Ahmedabad/Bengaluru/New Delhi
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 stive 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 Senior Clinical Database Developer (SCDD) is responsible for delivering high-quality electronic data capture (EDC) platform and clinical database study configurations. SCDDs work as an integral part of an agile team and serve as senior implementer or consultant on activities such as user acceptance testing (UAT) of EDC systems, data integration, upload, or transfer development, and global library/standards development. 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 provides technical subject matter expertise and may serve as a Product Owner or Scrum Master on the cross-functional Agile team.
Responsibilities:
Designs and configures electronic case report forms (eCRFs), (e.g., metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations); provides expertise in eCRF layout and is proficient in requirements writing
Configures complex protocols, visit schedules/folders and sites in relevant clinical data system builder or architect module
Configures complex system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system
Evaluates complex requirements, determines feasibility based on system capabilities, and proposes appropriate solutions
Performs eCRF and data system quality control, testing and verification activities with high degree of accuracy and consistency
Writes and executes test scripts for routine configurations and adapts complex test scripts
Performs EDC releases (Test, Train and Production), depending on the EDC system
Implements/programs Data Validation Plans/Specifications; programs SQL-based or configuration-based data validation checks. May create custom functions and procedures; may review or perform manual data changes
Implements CDISC standards such as CDASH and SDTM within the EDC system; may perform SDTM mapping using SQL or other language
Implements Data Migration Plans (e.g. study data import/export, clone or transfer of previous study); configures or develops 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 project 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; may participate in Agile cross-team coordination meetings to facilitate sharing of ideas and process improvements across teams
Mentors team members and demonstrates technical leadership within the team
Provides technical support to internal users for complex issues, reports defects
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 6 years of progressive clinical database development experience (or Master's degree and 4 years) and good 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 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 preferred
Excellent oral and written communication skills
Detail-oriented
Skills in prioritization, organization, and time management
Team player
Self-motivated and proactive
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