Site Compliance Lead
Core
Manages site compliance teams to ensure adherence to legal, regulatory, and company policies for clinical trial data quality and eCRF completion.
Role type
Site Compliance Lead (Manager)
Builds
Operational quality programs, data validation processes, and compliance dashboards for clinical sites.
Domain
Clinical Research / Clinical Operations / Regulatory Compliance
Required skills
Clinical trial process knowledge, Data management, Quality Management Systems (QMS), Protocol interpretation, Regulatory guidelines (GCP), Data analysis, eCRF management, Stakeholder collaboration
Preferred skills
SQL, Dashboard development, Training delivery, Audit report interpretation
Responsibilities
Manage staff including hiring, performance management, and coaching; Approve salary administration and corrective actions; Review and approve time records and expense reports; Complete or delegate Site Level Quality Reviews (SLQR); Perform quality control on site study data and eCRFs; Monitor training processes and timelines; Liaise with monitors, clients, and internal departments; Resolve data queries and report Quality Events; Ensure compliance with Good Clinical Practice and Data Protection Acts.
Seniority
Manager, supervising individual contributors and entry-level professionals