EDC Programmer

Tata Consultancy Services; São Paulo; Presencial; BRL 180 000 - 300 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Free 24/7 psychological support

Free TCS Learning Portal – Online/Live

Certifications reimbursement

International experience opportunity

Bring Your Buddy bonus

Resumo da oferta

Tata Consultancy Services is seeking an EDC Programmer to drive the configuration, development, and validation of EDC databases for clinical trials in Brazil. You will oversee eCRF implementation, UAT, and multi-environment management, while ensuring compliance with SOPs and data standards.

The role requires strong collaboration with Data Management and Standards teams and acts as SME for EDC-related activities, with opportunities to influence process improvements and adopt new capabilities.

Qualificações

• Experience with EDC programming, configuration, and database management.
• Experience developing and implementing eCRFs for clinical trials.
• Experience managing dynamic checks, edit checks, programmable protocol deviations, and EDC integrations.
• Experience configuring and managing clinical study environments.
• Experience executing UAT testing and validation activities.
• Knowledge of Clinical Data Acquisition Standards Harmonization (CDASH).
• Knowledge of Study Data Tabulation Model (SDTM) standards and concepts.
• Experience integrating EDC platforms with systems such as IRT, safety systems, and laboratory systems.

Responsabilidades

• Work on EDC programming activities and oversee the delivery of EDC databases and documentation to support clinical trial implementation and maintenance.
• Collaborate with study teams to develop eCRF specifications and build and/or oversee the implementation of Case Report Forms (eCRFs) in EDC.
• Manage EDC system configuration, dynamic checks, edit checks, programmable protocol deviations, and EDC integrations.
• Design, develop, and validate clinical studies in EDC.
• Manage edit check specifications and configure edit checks at the study level.
• Execute UAT scripts to test study and EDC platform configurations.
• Configure and manage multiple study environments, including UAT, Production, and Testing.
• Facilitate user access requests for study teams.
• Set up and manage blinded and unblinded study configurations.
• Serve as the Subject Matter Expert (SME) for EDC database-related activities at the study level.
• Configure, validate, and integrate modules within the EDC ecosystem, including coding, IRT, safety systems, and local laboratory integrations.
• Troubleshoot database configurations based on study requirements.
• Perform impact assessments for post-production changes.
• Prepare, test, and implement post-production changes.
• Support the adoption of new capabilities and business processes.
• Act as the primary contact for Clinical Technology vendors to ensure milestones are delivered with the highest level of quality.
• Work with Data Management and Standards teams to enhance existing processes.
• Apply CDASH and SDTM standards while following EDC platform best practices.

Conhecimentos

EDC programming

EDC configuration

EDC databases

eCRF development

UAT testing

CDASH standards

SDTM standards

Vendor coordination

SOP compliance

Study environments management

Ferramentas

EDC platforms

UAT scripting tools

Descrição da oferta de emprego

Come to one of the biggest IT Services companies in the world!! Here you can transform your career!

Why to join TCS?

Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.

We are looking for a EDC Programmer who wants to learn and transform his career.

In this role you will

• Work on EDC programming activities and oversee the delivery of EDC databases and documentation to support clinical trial implementation and maintenance.
• Collaborate with study teams to develop eCRF specifications and build and/or oversee the implementation of Case Report Forms (eCRFs) in EDC.
• Manage EDC system configuration, dynamic checks, edit checks, programmable protocol deviations, and EDC integrations.
• Design, develop, and validate clinical studies in EDC.
• Manage edit check specifications and configure edit checks at the study level.
• Execute UAT scripts to test study and EDC platform configurations.
• Configure and manage multiple study environments, including UAT, Production, and Testing.
• Facilitate user access requests for study teams.
• Set up and manage blinded and unblinded study configurations.
• Serve as the Subject Matter Expert (SME) for EDC database-related activities at the study level.
• Configure, validate, and integrate modules within the EDC ecosystem, including coding, IRT, safety systems, and local laboratory integrations.
• Troubleshoot database configurations based on study requirements.
• Perform impact assessments for post-production changes.
• Prepare, test, and implement post-production changes.
• Support the adoption of new capabilities and business processes.
• Act as the primary contact for Clinical Technology vendors to ensure milestones are delivered with the highest level of quality.
• Work with Data Management and Standards teams to enhance existing processes.
• Apply CDASH and SDTM standards while following EDC platform best practices.

Mandatory Skills

• Experience with EDC programming, configuration, and database management.
• Experience developing and implementing eCRFs for clinical trials.
• Experience managing dynamic checks, edit checks, programmable protocol deviations, and EDC integrations.
• Experience configuring and managing clinical study environments.
• Experience executing UAT testing and validation activities.
• Knowledge of Clinical Data Acquisition Standards Harmonization (CDASH).
• Knowledge of Study Data Tabulation Model (SDTM) standards and concepts.
• Experience integrating EDC platforms with systems such as IRT, safety systems, and laboratory systems.
• Ability to troubleshoot EDC database configurations and perform impact assessments.
• Experience implementing and managing post-production changes.
• Experience working in compliance with SOPs and clinical data management processes.
• Strong stakeholder management and vendor coordination skills.
• Experience serving as a Subject Matter Expert (SME) for EDC-related activities.
• Experience driving the adoption of new clinical technology capabilities and business processes.
• Advanced knowledge of EDC platform best practices.
• Experience supporting blinded and unblinded study configurations.
• Experience collaborating with Data Management and Standards teams.
• Experience working directly with Clinical Technology vendors.

What do we offer?

• TCS Cares – free 0800 that provides psychological assistance (24 hrs/day),
• legal, social and financial assistance to associates
• Partnership with SESC
• Reimbursement of Certifications
• Free TCS Learning Portal – Online courses and live training
• International experience opportunity
• Discount Partnership with Universities and Language Schools
• Bring Your Buddy – By referring people you become eligible to receive a bonus
• for each hire
• Xcelerate – Free Mentoring Career Platform
• Tata Consultancy Services is an equal opportunity employer, our commitment
• to diversity & inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of any socio-economic background, race, color, national origin, religion, sex, gender identity/expression , age, marital status, disability, sexual orientation or any others. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.
• At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!