Clinical Compliance Manager

📋 Description

• Offer effective leadership and guidance to sponsor R&D stakeholders on GCP-related activities and concerns, serving as a GCP expert and consultant for R&D colleagues.

• Serve as a Clinical Compliance member of clinical study teams within relevant Therapeutic Areas.

• Build strong relationships with R&D personnel across various functions and teams, providing coaching and compliance support as necessary.

• Collaborate with stakeholders to perform ongoing risk assessments of clinical trial activities to identify priority studies, compliance metrics for monitoring, high-risk vendors, and key compliance tasks (such as protocol reviews, vendor evaluations, and inspection readiness).

• Recognize and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and pertinent leadership, including the evaluation of serious breaches.

• Actively participate as a member of Contract Research Organization (CRO)/Vendor governance teams for designated Therapeutic Areas/Studies.

• Establish a relationship with CRO Quality Team members for continuous review of quality and compliance concerns.

• Engage in vendor evaluations as a Subject Matter Expert (SME) when required.

• Assist clinical teams/functions in formulating responses and CAPAs to findings from internal and external audits.

• Provide support and guidance for sponsor Quality Management System activities, including self-reporting deviations, conducting root cause analyses, and developing and evaluating CAPA plans.

• Recognize and anticipate trends in quality issues and collaborate with functional management to ensure timely implementation of risk-managed solutions.

• Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may affect drug development.

• Offer support and guidance during and after internal audits and external regulatory inspections as necessary.

• Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial execution and/or regulated drug development activities.

• Lead and manage inspection readiness activities, ensuring project teams are trained and prepared for regulatory inspections.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in life sciences or a related field.

• At least 5 years of experience in the CRO, pharmaceutical, or biotechnology industry, with a minimum of 3 years in a GCP clinical compliance, quality assurance, or regulatory compliance role.

• Comprehensive knowledge and understanding of drug development and the clinical trial process.

• Extensive knowledge of current regulatory and ICH GCP requirements, along with experience in international regulations, guidelines, and standards.

• Familiarity with CAPA management, risk management, regulatory inspections, and GLP requirements is advantageous.

• Excellent written and verbal communication skills, with the capacity to influence others and secure commitment.

• Ability to thrive in an entrepreneurial and fast-paced environment.

• Must be disciplined, detail-oriented, capable of multitasking, and able to work efficiently and independently.

• Proficient in collaborating and partnering with various internal business stakeholders.

• Ability to function effectively in a team setting.

• Highly developed problem-solving skills with the ability to resolve complex conflicts.

🏝️ Benefits

• Health insurance

• Flexible working arrangements