The CDP-II is responsible for the design, development, programming, validation, and maintenance of clinical trial databases throughout the study lifecycle. This includes clinical database build, Case Report Form (CRF) design, edit check programming, custom function development, external data integrations, data review listings, and data reconciliation activities. The CDP-II ensures all deliverables comply with company SOPs, ICH-GCP, CDISC standards, and applicable regulatory requirements while supporting high-quality clinical data management.
Responsibilities:
Design, build, validate, test, and maintain clinical trial databases using Medidata Rave, Veeva Vault EDC, and Viedoc EDC platforms in accordance with sponsor requirements and organizational standards.
Develop and maintain CRFs (Case Report Forms) based on study protocols and annotated CRFs, ensuring adherence to CDISC/CDASH or sponsor-specific standards.
Configure and program edit checks, derivations, custom functions, dynamic forms, visit structures, and workflow logic to ensure data quality and protocol compliance.
Develop and maintain custom functions, custom calculations, and automated data validation logic to support complex study requirements.
Perform external data integrations (e.g., Central Labs, ECG, ePRO/eCOA, IRT/RTSM, imaging, wearable devices, and other third-party vendor data), including defining and validating data transfer specifications and coordinating with external vendors.
Program and maintain data review listings, reconciliation reports, and discrepancy management reports to support ongoing clinical data review and cleaning activities.
Validate clinical databases through unit testing, integration testing, User Acceptance Testing (UAT), and database maintenance activities while ensuring complete documentation.
Ensure all programming activities are performed in accordance with company SOPs, Good Clinical Practice (ICH-GCP), and Good Programming Practices.
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Annotate CRFs according to CDISC standards (CDASH/SDTM) or sponsor-specific metadata requirements to facilitate downstream data standards implementation.
Provide technical expertise and guidance for database integrations, interfaces, and data exchanges between EDC systems and external reporting, statistical, and clinical data management systems.
Support computer system validation (CSV) activities and validation of electronic systems, software, and applications in compliance with applicable regulatory requirements.
Participate in project meetings, sponsor calls, and cross-functional discussions, providing technical support and collaborating with Clinical Data Management, Biostatistics, Statistical Programming, Medical Monitoring, and external vendors.
Support database amendments, mid-study updates, database lock activities, and post-production maintenance while ensuring data integrity throughout the clinical trial lifecycle.
Continuously learn and adopt new EDC technologies, programming techniques, industry standards, and best practices to improve database quality and operational efficiency.
Education:
Bachelor’s/ Master's degree in Life Sciences, Computer Science, Statistics, Data Science, Engineering, MCA, MSc - information technology/ Computer Science.
Pharmaceutical industry or CRO (Contract Research Organization) background.
Knowledge, Skills, and Abilities:
Hands-on experience with Medidata Rave programming, Veeva, and Viedoc platforms.
2–4 years of programming experience specifically in building study databases by interpreting clinical trial protocols
Knowledge in implementing CDISC principals including CDASH, TA level CRFs
Analytical & Technical Skills: Demonstrated ability in analytical thinking, problem solving, and applying technical solutions to complex challenges.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
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