Senior Clinical Database Programmer
Katalyst CRO, Cambridge, MA, United States
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.
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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.
#J-18808-Ljbffr