Job Description

Overview:
Associate Clinical Database Developer India Bengaluru
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 Associate Clinical Database Developer (ACDD) is responsible for assisting with delivering high

quality electronic data capture (EDC) platform and clinical database study configurations. ACDDs


work as an integral part of an agile team performing data system configuration, quality control,


testing, and may also provide support for activities such as user acceptance testing (UAT) of EDC


systems, creation of SQL-based or configuration-based data validation checks, and/or implement


CDISC standards such as CDASH and SDTM within the EDC system.
Responsibilities:
• Assists with design and configuration of electronic case report forms (eCRFs), (e.g.


metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations)
• Assists with configuring protocol, visit schedules/folders and sites in relevant clinical data


system builder or architect module
• Assists with configuration of system/database build features both within EDC and any


additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical


data system
• Assists in evaluation of requirements and determining feasibility based on system capabilities
• Performs eCRF and data system quality control, testing and verification activities
• Assists with adapting and executing test scripts for routine configurations
• May perform EDC releases (Test, Train and Production), depending on the EDC system
• Supports implementation of Data Validation Plans/Specifications; may support creation of


SQL-based or configuration-based data validation checks
• Assists with implementation of CDISC standards such as CDASH and SDTM within the EDC


system
• Supports implementation of Data Migration Plans (e.g., study data import/export, clone or


transfer of previous study)
• 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
• Provides technical support to internal users, 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
• Experience with database structures and programming languages a plus
• Experience with eCRF design and specifications development a plus
• 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

CONNECT WITH US! •Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes•