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6.0 - 10.0 years

1 - 1 Lacs

Hyderabad

Remote

Summary We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: • Author and execute test scripts in Veeva EDC, aligned with protocol requirements • Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms • Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices • Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior • Review data capture logic and support query testing to ensure data accuracy • Document test execution results, manage traceability, and support audit-readiness • Contribute to ongoing improvements in test processes across DCT systems Required Experience: • Strong, hands-on experience with Veeva CDMS (EDC) • Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) • Experience with IRT systems (e.g., Almac, 4G, Bioclinica) • Prior involvement in DCT environments, including testing for remote or device-based workflows • Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) • Detail-oriented with strong documentation and communication skills

Posted 16 hours ago

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5.0 - 8.0 years

15 - 20 Lacs

Hyderabad

Work from Office

Job purpose : The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities : Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested. Qualifications: BS/BA degree in Computer Science, or work-related experience. 5-8 years related experience. Experience with relational databases and Programming. Experience with developing eDC databases (e.g. Veeva Vault or RAVE), IRT systems (including randomization), and ePRO applications for data collection. Database programming language experience (e.g. SQL, PHP). Website programming language experience is a plus (e.g. HTML, Javascript) Statistical programming language experience is a plus (e.g. SAS, R, Python). Working knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Working conditions: This position operates in an office and/or remote setting. Job may additionally require incumbent to be available outside of regular 9-5 hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

Posted 1 month ago

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