Clinical Outcomes Solutions

Senior Clinical Data Manager – Elluminate Programming

Clinical Outcomes Solutions

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

SQL

About the role

  • Programming and Development: Write and maintain code for clinical trial data processes, including data extraction, transformation, and analysis using the multiple programming environment.
  • Data Management and Quality: Ensure accurate and timely delivery of clinical trial data by performing data checks, validation, testing, and reconciliation in line with clinical trial timelines and regulatory requirements.
  • Collaboration: Work closely with clinical data managers, statisticians, and other stakeholders to design and implement clinical data flow, ensuring compliance with all regulatory requirements.
  • Troubleshooting and Issue Resolution: Identify, investigate, and resolve any issues that arise within the platform or clinical data programming processes.
  • Documentation: Maintain comprehensive documentation of programming processes, code, and data management workflows for audit and regulatory purposes.
  • Continuous Improvement: Contribute to the improvement of programming practices, tools, and templates to streamline clinical programming workflows and enhance efficiency.
  • Training and Mentorship: Provide guidance and mentorship to junior programmers, ensuring adherence to best practices and facilitating knowledge sharing within the team.

Requirements

  • 4-6 years of experience in clinical programming and a background in Clinical Data Management
  • Proficient in clinical data programming languages (e.g., SAS, R, SQL, etc.).
  • Expertise in clinical programming platforms, including experience with clinical data workflows, data integration, and programming solutions.
  • Strong knowledge of clinical trial data structures, data standards (e.g., CDISC, SDTM), and regulatory requirements (e.g., FDA, EMEA).
  • Excellent troubleshooting and problem-solving skills with the ability to work under pressure to meet deadlines.
  • Strong communication skills with the ability to collaborate effectively with cross-functional teams and communicate technical concepts to non-technical stakeholders.
  • Bachelor’s degree or higher in Computer Science, Life Sciences, Engineering, or related field (or equivalent work experience).
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASRSQLclinical programmingdata extractiondata transformationdata analysisdata validationdata reconciliationprogramming solutions
Soft Skills
troubleshootingproblem-solvingcommunicationcollaborationmentorshipguidanceknowledge sharingattention to detailtime managementadaptability