Clinical Data & Operations Manager, Scientific Affairs

Added
1 day ago
Type
Full time
Salary
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Related skills

sql gcp dashboards hex emr

๐Ÿ“‹ Description

  • Support execution of sponsor studies per approved protocols, SOPs, and GCP
  • Maintain enrollment records and operational logs for sponsor review
  • Reconcile participant lists with safety, efficacy, and data sources
  • Prepare outputs for sponsor monitoring, audits, inspections
  • Update study SOPs, monitoring plans, and training materials
  • Write/review SQL queries to extract and validate study data

๐ŸŽฏ Requirements

  • Bachelorโ€™s degree in health/sciences or related field (or equivalent)
  • 5-7 years in clinical research, operations, or data operations in pharma/CRO
  • Hands-on sponsor monitoring, SDV, and data reconciliation experience
  • Strong SQL; querying relational databases for study data
  • Familiarity with GCP, ICH guidelines, and data quality/documentation
  • Experience building/validating dashboards in BI tools (Hex)

๐ŸŽ Benefits

  • Full medical, dental, and vision insurance + OneMedical membership
  • Healthcare and Dependent Care FSA
  • 401(k) with company match
  • Flexible PTO
  • Wellbeing + Learning & Growth reimbursements
  • Paid parental leave + Fertility benefits
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