About the Role:
As part of Novotech’s Clinical Data Programming unit, the Senior Clinical Data Programmer (SCDP) is responsible for database and application development work across multiple clinical data management projects, ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. The SCDP acts as primary point of contact for project team members to address and resolve issues at technical and DB development level.
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.
- 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.
Experience and Qualifications:
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.
- 6-8 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.
About Us
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
