Senior Associate, Clinical Compliance

Responsibilities

• Collaborate with Development Operations through all stages of clinical trial conduct to ensure GCP compliance; this includes but is not limited to the implementation of procedures and study documents and support of sponsor oversight activities
• Support the audit response process for Development Operations and follow CAPA commitments to completion
• Support global inspection readiness activities
• Support risk management activities
• Support Development Operations in noncompliance reporting and CAPA development
• Support and participate in internal audits and regulatory authority inspections as needed
• Support internal compliance assessments, including reporting of results to functional area leadership, initiating deviations, and managing associated CAPAs
• Analyze compliance data, create metrics, identify trends, and clearly communicate findings and recommended actions to management and stakeholders
• Support efforts to increase compliance awareness and a culture of compliance; includes but is not limited to leading office hours, presenting lessons learned and important compliance updates
• Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to support Development Operations alignment
• Lead by example to champion quality and compliance across the Development Operations organization

Qualifications

• Master’s and 3 years of relevant experience OR Bachelor’s and 5 years of relevant experience
• Knowledge of international GCP regulatory requirements and applicable national regulations (e.g., FDA, MHRA, etc.)
• Basic understanding of deviations, CAPAs, and risk management in clinical trials
• Excellent communication skills, able to provide clear and concise instructions
• Critical and creative thinking to be able to resolve complex problems