FEFA LLC is seeking a highly experienced and detail-oriented Clinical Research Quality Manager to join our team. The ideal candidate will have a strong background in overseeing clinical trials, performing quality visits, and creating Standard Operating Procedures (SOPs). This role is critical in ensuring the highest standards of quality and compliance in our clinical research activities.

REQUIREMENTS

• Bachelor’s degree in a relevant field (e.g., life sciences, healthcare, or related discipline). Advanced degree preferred.
• Minimum of 15 years of experience in clinical research, including overseeing clinical trials, performing quality visits, and creating SOPs.
• Experience with clinical project management, specifically as it related to quality.
• In-depth knowledge of GCP guidelines, regulatory requirements, and clinical trial processes.
• Strong analytical, problem-solving, and decision-making skills.
• Experience in data collection, analysis, and management for clinical trials or scientific research studies
• Proven track record of supervising and leading teams
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. Proficient in both written and verbal communication.
• Detail-oriented with a strong commitment to quality and compliance.
• Proficiency in compliance management in a clinical research setting
• Ability to manage multiple priorities and work under tight deadlines.
• Some travel is required throughout the US.
• Must be eligible to obtain and maintain a U.S. Federal Government Public Trust Clearance.

• Oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
• Conduct quality visits to clinical trial sites to assess compliance with study protocols, SOPs, and regulatory requirements.
• Develop, review, and implement SOPs to standardize clinical research processes and ensure consistency and quality.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and data management, to ensure the successful execution of clinical trials.
• Conduct internal audits and risk assessments to identify potential quality issues and implement corrective and preventive actions.
• Provide training and guidance to clinical research staff on quality standards, regulatory requirements, and SOPs.
• Monitor and report on the progress and quality of clinical trials, including preparing and presenting quality metrics and reports to senior management.
• Stay current with industry trends, regulatory changes, and best practices in clinical research quality management.
• Create tools and job aids to assist the team in achieving goals with efficiency and quality
• Critical thinking skills
• Monitor and evaluate clinic performance metrics to identify areas for improvement
• Develop and implement standard operating procedures (SOPs) to ensure efficient clinic operations
• Collaborate with physicians, nurses, and other healthcare professionals
• Ensure compliance with all regulatory requirements and ethical standards in clinical research
• Provide leadership, guidance, and training to staff, ensuring effective management and professional development.
• Works well remotely with a team