Senior Clinical Database Programmer
Katalyst CRO · Cambridge, MA · 1 mo ago
On-siteInformation TechnologyContract
Design, build, and configure clinical study databases in EDC/CDM platforms. Ensure systems meet client needs, follow GCDMP, and support accurate data capture, workflows, edit checks, and integrations.
Responsibilities
- Lead study build and database configuration in EDC systems.
- Configure edit checks, workflows, and validations.
- Gather and translate client requirements into technical solutions.
- Create specifications, test cases, and provide UAT support.
- Support integrations and data transfers with vendors.
- Deliver client workshops (remote and on‑site).
- Manage timelines, budgets, and project deliverables.
- Resolve implementation and configuration issues.
- Provide status reports to stakeholders.
- Mentor junior team members and train new hires.
- Drive process improvements and best practices.
- Ensure SOP and compliance adherence.
Requirements
- Strong knowledge of clinical trial processes.
- Hands‑on experience with Medidata Rave, Oracle Clinical, and OpenClinica.
- Expertise in study database build and configuration.
- Understanding of CDISC, data standards, and data management.
- Experience with UAT, QC testing, and functional documentation.
- Knowledge of integrations and data migration.
- Strong analytical and problem‑solving skills.
- Excellent communication and stakeholder management abilities.
- Team leadership and mentoring experience.