Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
About This Role:
Veranex has an exciting opportunity to join our team as a Sr Clinical Database Programmer. You will be part of a team working to improve lives globally through medical technology innovation. The Sr Clinical Database Programmer will be responsible for performing all study initiation set-up activities and attends kick-off meetings. Programs, performs unit testing, and maintains databases. Generates, maintains, and archives all study related documents. Participates in the setup and testing of the risk-based monitoring model and the Randomization and Trial Supply Management (RTSM) configuration testing. Assists with internal audits and attends sponsor audits. Trains and mentors new or junior programmers. Performs batch upload / data upload tasks in support of IRT integration. Provides advanced technical expertise and support to clinical database programming and data management teams.
What You Will Do:
- Demonstrate strong expertise in complex custom function programming, including advanced edit checks, derivations, and system validations to support complex protocols and study designs.
- Demonstrate strong expertise in protocol interpretation, translating complex protocol requirements into robust EDC designs, CRFs, edit checks, and database specifications.
- Lead end-to-end clinical database design, development, and delivery for complex studies, acting as Study Lead and single point of contact for sponsors and cross-functional teams.
- Provide hands-on experience in TSDV, RTSM setup, testing, integrations, and issue resolution; experience in RTSM is a strong added advantage.
- Strong expertise in managing post production change requests, such as mid study updates, protocol amendments, impact assessment, revalidation, and controlled deployments and migration while ensuring data integrity.
- Mentor junior programmers, manage timelines and deliverables, proactively identify risks, and ensure high-quality outputs aligned with SOPs, client expectations, and regulatory standards.
- 7-9 years of relevant work experience in custom functions
Qualifications:Required skills:
- Bachelor’s degree or international equivalent in computer science or related field.
- 7 - 9 years of relevant work experience
- A seasoned professional with full understanding of area of specialization. Resolves a wide range of issues in creative ways. Fully qualified level of the role.
- Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors.
- Exercises judgment in selecting methods and techniques for obtaining solutions.
- Networks with senior internal and external personnel in area of expertise.
- Works independently; receives minimal guidance on day-today work and new projects or assignments.
Preferred:
- In-depth knowledge of clinical research and the drug development process
- Strong knowledge of medical terminology, Good Clinical Practices (ICH GCP), CDASH, and DISC
- In-depth knowledge of databases, validation, programming, word-processing and spreadsheet software
- Strong knowledge of programming languages
- Strong programming skills
- Strong written and Oral communication skills
- Excellent attention to detail
- Ability to solve moderate to complex problems
- Strong ability to effectively manage multiple tasks and projects
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
