The Senior Compliance Specialist is responsible for performing activities within the assigned country/countries that ensure an integrated and comprehensive quality and compliance approach for clinical trials
Job Summary
The Senior Compliance Specialist is responsible for performing activities within the assigned country/countries that ensure an integrated and comprehensive quality and compliance approach for clinical trials.
Key responsibilities include monitoring compliance risk, performing QC checks, supporting root cause analysis, and facilitating local inspections and audits.
The role involves collaborating with local and central business partners to ensure timely CAPA setting and implementation, and providing advice regarding SOP, system, and GCP questions.
Matching Summary
The Senior Compliance Specialist is responsible for performing activities within the assigned country/countries that ensure an integrated and comprehensive quality and compliance approach for clinical trials.
Skills & Requirements
Must-have
Quality and compliance oversight
Clinical trial compliance
Risk-based activities
Root cause analysis
CAPA setting and implementation
Local regulatory intelligence
Nice-to-have
Inclusive work environment
Respect diversity and dignity
Conflict resolution/management
Create win-win situations
Key Requirements
Bachelor's degree in science or Medicine or 5 years relevant experience
At least 4 years of site/trial management experience
Knowledge of FDA/ICH and country-specific regulations