Collaborate with Development Operations through all stages of clinical trial conduct to ensure GCP compliance
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
Analyze compliance data, create metrics, identify trends, and communicate findings to management and stakeholders
Support efforts to increase compliance awareness and a culture of compliance
Maintain awareness of changes within the industry and regulatory environment

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
Ability to develop innovative solutions to maximize efficiency
Ability to prioritize and adjust workload with guidance

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Senior Associate, Clinical Compliance

Key skills