Director, Clinical QA Management RWE Clinical Trials - Remote

About the positionThe Director, Clinical Quality Assurance Management for the RWE Clinical Trial business at bolthires is responsible for overseeing quality activities at both the business and clinical trial site levels. This role ensures that clinical trials are conducted in compliance with Good Clinical Practice (GCP) standards and regulatory obligations, while also focusing on continuous improvement and risk management. The director will lead a team of Quality Assurance professionals and will be instrumental in developing and implementing quality management systems and training programs.Responsibilities • Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates. • Identify appropriate staff SOP training requirements and maintain oversight of training to ensure compliance. • Implement and maintain a Quality Management System (QMS) in line with the Corporate QMS. • Build, manage, lead and motivate a QA team, ensuring recruitment and retention of skilled professionals. • Ensure quality and operational compliance; act as a subject matter expert for quality investigations and audits.• Develop and implement a risk-based and flexible approach to QA in compliance with regulatory requirements. • Generate and analyze metrics to track KPIs on a weekly, monthly, and quarterly basis. • Work with Operations team to implement and maintain tracking of incidents within clinical trials. • Lead the Audit Program management process, including internal and external operations assessments. • Partner with functional areas in study design, data collection, and reporting activities. Requirements • Comprehensive understanding of GCP, CFR, and ICH guidelines.• Significant experience managing clinical quality activities and knowledge of clinical operations. • Experience with clinical trial site/process audits and regulatory inspections. • Experience in line management of employees. • Experience translating Pharma/Sponsor needs for innovative quality management. • Excellent leadership and interpersonal skills. • Excellent verbal and written communication and presentation skills. • Demonstrated adaptability and resourcefulness in a start-up environment. • At least 2 years of experience contributing to financial decisions.• At least 3 years of direct or indirect leadership experience. Nice-to-haves • Experience in a start-up environment. Apply tot his job