Senior Clinical Database Programmer

Katalyst CRO; Cambridge (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO, located in Cambridge, Massachusetts, is looking for a Clinical Database Designer. The role involves designing and configuring clinical study databases within EDC/CDM platforms while ensuring adherence to client needs and compliance standards. Responsibilities include leading study builds, configuring workflows, mentoring team members, and managing project deliverables. Candidates should have extensive knowledge of clinical trial processes and experience with Medidata Rave, Oracle Clinical, and OpenClinica. Excellent communication and analytical skills are crucial for success in this role.

Qualifications

• 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/Data Management.
• Experience with UAT, QC Testing, and Functional Documentation.
• Knowledge of Integrations/Data Migration.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management skills.
• Experience in team leadership and mentoring.

Responsibilities

• Lead Study Build and Database Configuration in EDC systems.
• Configure Edit Checks, Workflows, and Validations.
• Gather and translate client requirements into solutions.
• Create Specifications, Test Cases, and provide UAT Support.
• Support integrations and data transfers with vendors.
• Deliver client workshops (remote/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.

Skills

Clinical Trial Processes

Medidata Rave

Oracle Clinical

OpenClinica

Analytical skills

Problem-solving skills

Communication skills

Stakeholder management

Team leadership

Job description

Job Description

Design, build, and configure clinical study databases in EDC/CDM platforms. Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations.

Responsibilities

• Lead Study Build / Database Configuration in EDC systems.
• Configure Edit Checks, Workflows, Validations.
• Gather & translate client requirements into solutions.
• Create Specifications / Test Cases / UAT Support.
• Support integrations & data transfers with vendors.
• Deliver client workshops (remote/on-site).
• Manage timelines, budgets & project deliverables.
• Resolve implementation / configuration issues.
• Provide status reports to stakeholders.
• Mentor junior team members / train new hires.
• Drive process improvements & best practices.
• Ensure SOP / compliance adherence.

Requirements

• Strong knowledge of Clinical Trial Processes.
• Hands‑on experience with Medidata Rave, Oracle Clinical, OpenClinica.
• Study database build & configuration expertise.
• Understanding of CDISC / Data Standards / Data Management.
• UAT, QC Testing, Functional Documentation.
• Integrations / Data Migration knowledge.
• Strong analytical & problem‑solving skills.
• Excellent communication & stakeholder management.
• Team leadership / mentoring experience.