Clinical Compliance Manager - US - FSP

The Clinical Compliance Manager will provide GCP compliance support to therapeutic area and clinical study teams under the direction of the Sr. Manager or the Associate Director, Clinical Compliance. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines, and sponsor Standard Operating Procedures (SOPs) for the conduct of clinical studies.

The position will utilize a risk-based strategy to prioritize compliance support for clinical activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. The Clinical Compliance Manager serves as an important conduit to the broader organization to ensure a culture of quality and compliance.

Responsibilities

• Provide quality leadership and direction to sponsor R&D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R&D colleagues.

• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.

• Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.

• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).

• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.

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

• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.

• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.

• Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.

• Provide support and guidance for sponsor Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.

• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.

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

• Provide support and guidance during and following internal audits and external regulatory inspections (as required).

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

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

Requirements:

• Bachelor’s degree is required, life science or related discipline preferred.

• Minimum of 5 years in CRO, pharmaceutical or biotechnology industry experience, with 3+ years in a GCP clinical compliance, quality assurance, or regulatory compliance role.

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

• In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.  Working knowledge of CAPA management, risk management, regulatory inspections and GLP requirements is a plus.

• Excellent written and verbal communications skills with the ability to influence others and gain commitment.

• Ability to work in an entrepreneurial and fast-paced culture.

• Must be disciplined, detail-oriented, and able to multitask and work efficiently and independently.

• Ability to collaborate and partner with various internal business partners.

• Ability to work in a team environment.

• Highly developed problem-solving skills and the ability to resolve difficult conflicts.