eClinical Solutions

SaaS data management for clinical trials

Clinical Database Programmer

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Requirements

A bachelor's degree or equivalent work experience is preferred.
Two or more years of experience in the pharmaceutical or biotechnology industry, or equivalent, is preferred.
Experience gathering requirements and developing CRF designs and specifications, edit checks, and site queries, with understanding of database structures and programming languages.
Ability to work creatively and independently on complex assignments.
Ability to communicate and work effectively and cooperatively with professional staff members.
Detail orientation and ability to multitask, prioritize, plan, and organize.
Excellent verbal and written English communication skills.
Proficiency in Microsoft Office applications, specifically Microsoft Project and Microsoft Excel.
Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology is preferred.
Programming experience with C#.
Expert knowledge of Medidata Clinical Cloud, especially Rave EDC capabilities and best practices.
Familiarity with clinical systems and technologies such as ePRO, IVRS/IWRS, and CTMS.
Experience with data reporting tools such as Business Objects, JReview, Cognos, or Crystal Reports, or related tools, is preferred.

Responsibilities

Design, develop, and test clinical databases, including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, and standard and custom reports.
Perform peer reviews of studies built by other Clinical Database Programmers.
Develop and maintain database builds and EDC standards in compliance with requirements and in support of clinical studies, including Global Library, Edit Checks, and CRF modules.
Manage timely, high-quality deliverables for study teams on assigned protocols or studies.
Serve as an EDC subject matter expert, providing guidance and best-practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality.
Maintain a project-level perspective and communicate as the Medidata Clinical Cloud subject matter expert on technical and functional electronic data capture programming and data management activities, timelines, and deliverables.
Perform other duties as assigned.

Clinical Database Programmers are operationally responsible to provide technical support and oversight for the Medidata Clinical Cloud (MCC) implementation activities. Clinical Database Programmers will maintain project level perspective, focus and communicate effectively as the MCC SME on technical and functional electronic data capture programming and data management activities, timelines and deliverables.

KEY TASKS & RESPONSIBILITIES

Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports
Performs peer review for the studies built by other Clinical Database Programmers
Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules
Manages timely-quality deliverables for the study teams for assigned protocol/study(s)
Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality
Working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules.
Other duties as assigned

CANDIDATE’S PROFILE

Education & Experience

Bachelor’s degree or equivalent work experience preferred
2+ years in Pharmaceutical/Biotechnology industry or equivalent preferred
Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages

Professional Skills

Ability to work creatively and independently to carry out assignments of a complex nature
Ability to communicate and work effectively and cooperatively with other professional staff members
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Excellent knowledge of English; verbal and written communication skills

Technical Skills

Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferred
Programming Languages: C#
Expert knowledge of Medidata Clinical Cloud (MCC) especially Rave EDC capabilities and best practices
Familiarity with Clinical Systems and technologies: ePRO, IVRS/IWRS, CTMS
Experience with Data Reporting Tools: Business Objects, JReview, Cognos, Crystal Reports or related preferred

About the Company

eClinical Solutions

SaaS data management for clinical trials

eClinical Solutions provides data management and analytics for clinical trials in the biopharma sector. Its platform, elluminate, is a SaaS that integrates data from many sources to enable comprehensive statistical analyses and operational insights, supported by professional services. The product works by centralizing diverse trial data in a single system, allowing users to run analyses, generate insights, and collaborate across teams, with scalability and adaptability to program changes. Compared with competitors, the company combines a specialized, data-centric platform with ongoing consulting services, offering end-to-end data integration, analytics, and operational support that helps clients manage large amounts of trial data and adapt quickly. The goal is to accelerate the development of new treatments and improve trial efficiency by modernizing data management and enabling faster, data-driven decisions.

Company size: 201-500
Company stage: Not listed
Total funding: Not listed
Headquarters: Mansfield, MA
Founded: 2012

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