May serve as a technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical……
Develops complex SAS programs that develop models to analyze and tablulate clinical study reports in line with CDISC. Serves as an expert troubleshooter.…
Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical……
Perform impact analysis and risk assessment on all proposed application changes. Experience in form design and programming in an EDC, such as Medidata Rave,……
Drive implementation of Metadata Repository (MDR) capabilities focused on front-end mapping (CRF to SDTM). Bachelor’s degree in Life Sciences, Computer Science,……
Participate in relevant study and project team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion……
You'll collaborate cross-functionally to design, build, validate, and maintain clinical databases, develop programming solutions and data visualizations, and……
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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.
The minimum salary is $89K and the max salary is $128K.
$89K – $128K/yr (Glassdoor est.)
$107K
/yr Median
Austin, TX
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