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Description

• Works collaboratively across multiple functional areas: (e.g., Clinical Operations, Biometrics, Clinical Development, Drug Safety, Regulatory Affairs, Project Management), and with CRO and other trial vendors, to meet clinical data management deliverables consistent with clinical trial timelines
• Responsible for eCRF design, development, validation, and maintenance of clinical study databases for clinical trials
• Monitors Data Management processes and CRO performance in US and EU
• Performs/oversees data review and cleaning activities, including EDC reconciliation with all external datasets (e.g., safety, biomarkers, IRT, central imaging), and assure quality interim and final reporting of clinical data
• Generates and/or review/approve study documents (e.g., Data Management Plans, data transfer specifications, SAE and/or external (e.g., biomarker) data reconciliation plans, coding conventions, study protocols)
• Ensures the quality of clinical data to meet standards for regulatory submissions. Generate and/or implement the Data Quality Review Plan (DQRP) defining and documenting the data quality, review strategy for each clinical trial in collaboration with cross-functional team, enabling the ongoing quality review of patient data supporting regulatory filings, publications, and other high-profile business activities
• Generates and/or distributes data management metrics, data listings and status reports
• Contributes to the ongoing development, review, and revisions of Clinical Data Management Standard Operating Procedures (SOPs) and standard CDM templates
• Collaborate cross-functionally to resolve or escalate data management issues, and ensure effective communication throughout all clinical trial phases
• Knowledge of FDA regulations and industry best practices (e.g., GCP, 21 CFR Part 11, ISO 14155)
• Performs miscellaneous job-related duties as assigned

Job Requirements

• B.S. /B.A. in a science or technical discipline degree with 10 years of experience in clinical data management, or M.S in a science or technical discipline degree with 8 years of experience in clinical data management
  • Experience supporting the Oncology Therapeutic area
• Expertise with multiple EDC platforms
• Demonstrated success managing Clinical Data Management within an outsourced data management model
• Experience working in an FDA regulated environment
• Solution-oriented mindset with excellent attention to detail
• Open to continuous improvement
• Exceptional spoken and written communication ability