Clinical Research Quality Manager

FEFA, LLC; Washington (District of Columbia); Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Clinical Research Quality Manager to ensure the highest standards of quality in clinical trials. This role involves overseeing compliance with regulatory requirements, developing SOPs, and conducting quality visits to clinical trial sites. The ideal candidate will have extensive experience in clinical research, strong analytical skills, and a commitment to quality and compliance. Join a forward-thinking team dedicated to excellence in clinical research and make a significant impact in the healthcare field.

Qualifications

• 15+ years of experience in clinical research and quality management.
• Strong knowledge of GCP guidelines and regulatory requirements.

Responsibilities

• Oversee clinical trials ensuring compliance with regulatory requirements.
• Develop and implement SOPs for clinical research processes.
• Conduct quality visits and internal audits to assess compliance.

Skills

Clinical Trials Oversight

Quality Assurance

Standard Operating Procedures (SOPs)

Regulatory Compliance

Analytical Skills

Leadership

Communication Skills

Education

Bachelor's degree in Life Sciences

Advanced degree (preferred)

Job description

Join to apply for the Clinical Research Quality Manager role at FEFA, LLC.

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.

Responsibilities

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

Requirements

1. Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or related discipline). Advanced degree preferred.
2. Minimum of 15 years of experience in clinical research, including overseeing clinical trials, performing quality visits, and creating SOPs.
3. Experience with clinical project management, specifically related to quality.
4. In-depth knowledge of GCP guidelines, regulatory requirements, and clinical trial processes.
5. Strong analytical, problem-solving, and decision-making skills.
6. Experience in data collection, analysis, and management for clinical trials or scientific research studies.
7. Proven leadership in supervising and guiding teams.
8. Excellent communication and interpersonal skills, with proficiency in both written and verbal communication.
9. Attention to detail with a strong commitment to quality and compliance.
10. Proficiency in compliance management within a clinical research setting.
11. Ability to manage multiple priorities and work under tight deadlines.
12. Some travel required throughout the US.
13. Must be eligible to obtain and maintain a U.S. Federal Government Public Trust Clearance.