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:
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.
- 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.