Clinical Program Quality Excellence Lead – FSP Team

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Facilitate and oversee cross-functional teams’ GCP inspection readiness and execution activities throughout the entire study lifecycle.

• Integrate real-time inspection readiness strategies into daily operations alongside study teams, Global Development Compliance, and Clinical Quality Assurance.

• Advise study teams on adherence to operational processes and ensure well-prepared documentation for global studies and programs.

• Provide timely guidance on operating model processes and necessary documentation.

• Create and maintain inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.

• Assist in the development of inspection deliverables, including listings, functional presentations, issue-related storyboards, and audit/inspection preparations.

• Act on compliance monitoring signals and study health metrics to address real-time issues.

• Involve Sponsor and CRO subject matter experts in inspection readiness and study-level risk assessments.

• Supervise TMF performance and processes, risk-based oversight strategies, TMF Plan and TMF Index adherence, and elements from outsourced CROs.

• Lead and contribute to Strategy Team Meetings and Lead Core Team Meetings.

• Communicate and escalate issues internally and externally with vendors.

• Maintain project management documentation, including plans, timelines, and progress reports.

• Coordinate study team preparedness for internal audits and regulatory inspections.

• Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses.

• Facilitate and monitor study-specific CAPA activities in conjunction with GCP Compliance Management and QA.

• Identify and implement enhancements in inspection readiness and study execution processes.

• Provide regular status updates to stakeholders and leadership.

• Ensure real-time alignment with functional SMEs and cQA throughout the study lifecycle and during audits and inspections.

⛳️ Requirements

• A minimum of 6+ years of clinical research experience within the pharmaceutical or biotechnology sector.

• Strong understanding of and experience with GCP compliance, regulatory inspection readiness, and study execution processes.

• Experience with CROs and outsourced clinical trial activities; sponsorship experience is preferred.

• Comprehensive knowledge of drug development and clinical trial processes, including relevant standards and documentation.

• Experience in managing and overseeing clinical trials systems; familiarity with Veeva is preferred.

• Proven understanding of sponsor oversight requirements and regulations.

• Experience in problem-solving, negotiations, and collaborative team-building with non-direct reports and other stakeholders.

• Strong project management and communication skills to effectively assess risks, establish priorities, take initiative, and meet deadlines.

• Ability to thrive in a fast-paced, dynamic environment while prioritizing multiple competing tasks and demands.

• Solid knowledge of regulatory requirements governing clinical trials and industry best practices.

• A Bachelor's degree is preferred or equivalent experience.

• Proficiency in utilizing Microsoft Office and software for general use, project management, and presentations.

• Extensive understanding of the pharmaceutical industry.

• Advanced expertise in GCP, ICH, and applicable global and local regulatory standards governing clinical research.

• Advanced knowledge of complex Trial Master File deliverables, TMF structures, and electronic document management systems, including CTMS, SSU, and eTMF.

• Ability to quickly learn new systems and technology and provide training to cross-functional study teams.

• Capacity to monitor, interpret, and act on key performance metrics, including study compliance and TMF health data.

• Ability to collaborate across functions, regions, and cultures.

• Aptitude for managing deliverables, leading others, and driving projects forward.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.