Senior Clinical Data Manager / EDC & eCRF Designer

Octalsoft LLC; Ahmedabad District; Presencial; INR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Octalsoft LLC is seeking a Clinical Data Management professional to design and build EDC databases and eCRFs based on trial protocols. You will develop edit checks, ensure data quality, and align data collection with CDISC/CDASH standards across studies.

You will coordinate UAT, manage database updates, and ensure adherence to GCP and FDA 21 CFR Part 11, collaborating with Clinical Operations, Biostatistics, CROs, and stakeholders for study-specific requirements.

Formación

• 2-4 years of relevant experience in Clinical Data Management, EDC database building, or eCRF development.
• Hands-on experience with at least one EDC platform such as Medidata Rave, Oracle Clinical One, Veeva Vault CDMS, or Castor.
• Working knowledge of CDISC, CDASH, and SDTM standards.
• Understanding of edit check programming, validation rules, derivations, and conditional logic.
• Familiarity with SQL, JavaScript, or EDC-specific programming and configuration logic is an advantage.
• Knowledge of clinical trial protocols, Data Management Plans, UAT, and database validation.
• Understanding of GCP and FDA 21 CFR Part 11 requirements.

Responsabilidades

• Design, configure, and build EDC databases and eCRFs based on clinical trial protocols and DMPs.
• Develop and validate edit checks, skip logic, data validation rules, and automated queries to maintain data quality.
• Implement standardized data collection practices aligned with CDISC/CDASH standards and SDTM requirements.
• Prepare and execute UAT test scripts, document test results, and coordinate testing with cross-functional teams.
• Manage protocol amendments, mid-study database updates, user access, and EDC configuration changes.
• Collaborate with Clinical Operations, Biostatistics, CROs, and other stakeholders to ensure study-specific requirements are implemented.
• Maintain documentation and support compliance with GCP, FDA 21 CFR Part 11, and related procedures.
• Troubleshoot EDC-related issues and support successful study implementation and maintenance.

Conocimientos

EDC database building

eCRF development

CDISC/CDASH/SDTM

Edit checks/validation

SQL/JavaScript/EDC programming

GCP/FDA 21 CFR Part 11

Clinical trial knowledge

Educación

Bachelor's degree in Life Sciences/Pharmacy/CS/Health Informatics

Herramientas

Medidata Rave

Oracle Clinical One

Veeva Vault CDMS

Castor

Descripción del empleo

Company Description

Octalsoft LLC advances clinical trials by applying AI and machine learning technologies to deliver high-value, scalable solutions for clients across the health tech ecosystem. The company focuses on building robust, cost-efficient platforms that help organizations solve complex business challenges and achieve their strategic goals. Octalsoft's solutions support Sponsors, CROs, Sites, and Depots in transforming how they conduct clinical research and engage with stakeholders. By driving innovation in health technology, Octalsoft aims to improve patient outcomes and enhance quality of life through streamlined, data-driven clinical operations

Key Responsibilities

• Design, configure, and build EDC databases and electronic Case Report Forms (eCRFs) based on clinical trial protocols and Data Management Plans (DMPs).
• Develop and validate edit checks, skip logic, data validation rules, and automated queries to maintain data quality.
• Implement standardized data collection practices aligned with CDISC/CDASH standards and support SDTM-related requirements.
• Prepare and execute UAT test scripts, document test results, and coordinate testing with cross-functional teams.
• Manage protocol amendments, mid-study database updates, user access, and EDC configuration changes.
• Collaborate with Clinical Operations, Biostatistics, CROs, and other stakeholders to ensure study-specific requirements are accurately implemented.
• Maintain appropriate documentation and support compliance with GCP, FDA 21 CFR Part 11, and applicable clinical data management procedures.
• Troubleshoot EDC-related issues and support the successful implementation and maintenance of clinical studies.

Company Description

Octalsoft LLC advances clinical trials by applying AI and machine learning technologies to deliver high-value, scalable solutions for clients across the health tech ecosystem. The company focuses on building robust, cost-efficient platforms that help organizations solve complex business challenges and achieve their strategic goals. Octalsoft's solutions support Sponsors, CROs, Sites, and Depots in transforming how they conduct clinical research and engage with stakeholders. By driving innovation in health technology, Octalsoft aims to improve patient outcomes and enhance quality of life through streamlined, data-driven clinical operations

Key Responsibilities

• Design, configure, and build EDC databases and electronic Case Report Forms (eCRFs) based on clinical trial protocols and Data Management Plans (DMPs).
• Develop and validate edit checks, skip logic, data validation rules, and automated queries to maintain data quality.
• Implement standardized data collection practices aligned with CDISC/CDASH standards and support SDTM-related requirements.
• Prepare and execute UAT test scripts, document test results, and coordinate testing with cross-functional teams.
• Manage protocol amendments, mid-study database updates, user access, and EDC configuration changes.
• Collaborate with Clinical Operations, Biostatistics, CROs, and other stakeholders to ensure study-specific requirements are accurately implemented.
• Maintain appropriate documentation and support compliance with GCP, FDA 21 CFR Part 11, and applicable clinical data management procedures.
• Troubleshoot EDC-related issues and support the successful implementation and maintenance of clinical studies.

Required Skills & Qualifications

• 2-4 years of relevant experience in Clinical Data Management, EDC database building, or eCRF development.
• Hands-on experience with at least one EDC platform, such as Medidata Rave, Oracle Clinical One, Veeva Vault CDMS, or Castor.
• Working knowledge of CDISC, CDASH, and SDTM standards.
• Understanding of edit check programming, validation rules, derivations, and conditional logic.
• Familiarity with SQL, JavaScript, or EDC-specific programming and configuration logic is an advantage.
• Knowledge of clinical trial protocols, Data Management Plans, UAT, and database validation.
• Understanding of GCP and FDA 21 CFR Part 11 requirements.
• Bachelor's degree in Life Sciences, Pharmacy, Computer Science, Health Informatics, or a related discipline.
  

• If you have hands-on experience in EDC database development and eCRF design and are passionate about improving clinical data quality through technology, we would love to hear from you.