Biostatistician designing real - world evidence studies from EMR and claims data for Syneos Health. Applying causal inference, trial emulation, and statistical programming across healthcare projects.
About the role
- Principal Clinical Data Manager leading clinical research data management, quality, and database lock activities at Veristat. Managing complex studies and mentoring clinical data management teams.
Responsibilities
- Perform data management tasks from study start-up through database lock for assigned clinical research projects
- Manage paper-based and electronic data capture (EDC) studies
- Ensure overall data quality and documentation on clinical research projects
- Work on mid-to-large complex projects across various indications
- Serve as program manager when needed, overseeing multiple studies under the same client
- Lead teams of clinical data managers
- Ensure contracted activities follow Veristat Standard Operating Procedures and/or sponsor-specific requirements
- Promote consistent operations, efficient resource use, and knowledge sharing with Data Management leadership
- Assist with training data managers on project-specific and general data management processes, procedures, and systems
- Provide training to other company functions as needed
Requirements
- Bachelor’s degree in a related field
- 7+ years of relevant experience
- At least 5 years’ experience in clinical data management in a clinical research setting
- 4 years of experience in leading project teams
- Thorough knowledge of ICH Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines
- Knowledge of medical terminology, clinical trials, and clinical research
- Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotech companies
- Demonstrated technical leadership skills
- Ability to serve as an internal and external consultant and influence without authority
- Expert-level computer technology skills, including clinical trial databases and applications such as IBM Clinical Development and Medidata RaveX
- Understanding of project planning and management methods
- Excellent interpersonal, communication, and organizational skills
- Ability to work independently and in a team environment
- Ability to mentor teams and provide data management expertise
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
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