SuperStaff

Comprehensive BPO, RPO, and Call Center Outsourcing Solutions for Growing Businesses

Principal Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteTeam 201-500Since 2009H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

16 days ago

Salary

Not specified

Bachelor Degree5 yrs expEnglish

Job Description

• Collaborate on the redesign and optimization of end-to-end data management processes including study start-up, maintenance, and close-out. • Evaluate and revise existing procedures to align with internal execution capabilities, ensuring operational efficiency, compliance, and scalability. • Provide strategic oversight of functional improvements across data management operations. • Oversee and contribute to the reengineering and execution of critical data management functions, including: • Study Set-Up • EDC Build and Maintenance • Data Cleaning and Query Management • Local Laboratory and External Data Handling • Clinical Coding • SAE Reconciliation • Blinding Procedures • Site Close-Out and Database Lock • Data Management Metrics and Clean Patient Tracker oversight • Ensure all data management activities comply with applicable regulatory requirements, CDISC standards, and internal quality standards. • Support audit readiness, inspection preparedness, and continuous quality improvement initiatives. • Identify and mitigate data-related risks proactively. • Represent the Data Management function within the clinical trial working group. • Ensure aligned expectations for all data-related deliverables, especially those supporting regulatory submissions and key milestone decisions. • Collaborate closely with Clinical Operations, Statistical Programming, Biostatistics, and other stakeholders to ensure timely database lock and delivery of high-quality data. • Provide influential leadership to ensure milestones and deliverables are met within timelines and budget. • Contribute to continuous improvement initiatives at the functional and organizational levels.

Job Requirements

  • Bachelor’s degree in Life Sciences, Health Informatics, or related field
  • Minimum of 5 years of progressive experience in clinical data management
  • Demonstrated experience in end-to-end study data management (start-up through database lock)
  • Proven expertise in process development, SOP writing, and process reengineering
  • Strong knowledge of EDC systems and clinical data workflows
  • Solid understanding of CDISC standards and global regulatory requirements
  • Experience working cross-functionally within global clinical trial teams
  • Preferred Qualifications (Optional):**
  • Experience in sponsor-dedicated or fully embedded pharmaceutical environments
  • Experience leading or mentoring junior data managers
  • Experience supporting regulatory submissions (e.g., NDA, BLA, MAA)
  • Experience with risk-based monitoring environments
  • Educational Requirements & Certifications:**
  • Bachelor’s degree in Life Sciences, Health Informatics, or related field (required)
  • Advanced degree (Master’s) in related discipline (preferred)
  • CDISC certification or related industry certification (preferred)

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