Beschreibung

In this role, you will oversee compliance and quality support for clinical studies, ensuring adherence to regulations while fostering collaboration among teams. Your day-to-day responsibilities will involve identifying compliance issues, leading improvements, and preparing for inspections, all aimed at optimizing clinical operations.

Anforderungen

• •Expertise in GCP and clinical operations
• •High level of clinical operations knowledge
• •Strong analytical and managerial skills
• •Appropriate escalation of quality issues
• •Excellent English communication and interpersonal skills
• •Excellent organizational, presentation, and training skills
• •Ability to work independently in multi-cultural settings
• •Bachelor’s degree in scientific, medical, or healthcare discipline
• •Minimum 14 years’ experience in GCP compliance or equivalent role
• •Experience in oncology global trials
• •PC literacy and MSOffice skills

Aufgaben

• •Implement Global Clinical Compliance strategies
• •Provide compliance oversight for assigned studies
• •Ensure inspection readiness and regulatory compliance
• •Identify and escalate non-compliance issues
• •Track non-compliance issues and quality events
• •Support GCP readiness activities and programs
• •Adhere to ICH/GCP and local regulations
• •Contribute to Clinical Operations Work Instructions and SOPs
• •Demonstrate clinical study experience and trial management
• •Support inspection preparation and response management
• •Lead and guide Regional Clinical Compliance stakeholders
• •Foster collaboration with key stakeholders
• •Draft responses and corrective action plans for audits
• •Identify compliance matters and drive improvements
• •Provide GCP compliance guidance to stakeholders
• •Ensure escalation of GCP non-compliance issues
• •Develop and implement CAPA for compliance issues
• •Manage Site & Sponsor inspections
• •Develop GCP inspection readiness programs
• •Feed audit findings into training materials
• •Approve compliance visit scheduling and preparation
• •Peer review compliance assessment reports
• •Monitor Key Compliance Indicators and develop metrics
• •Conduct trend analysis for compliance risks
• •Establish preventive action initiatives
• •Drive internal GCP compliance process improvements
• •Lead GCP compliance training material development
• •Provide expertise on clinical trial processes
• •Offer feedback on investigator site performance
• •Stay updated on regulations and industry trends
• •Oversee direct/indirect reports' work
• •Conduct regular performance appraisals and feedback
• •Engage in career development planning for team members
• •Mentor Clinical Compliance team members

Tools & Technologien