Clinical Trials Quality Manager

Headlands Research, Inc.; Idaho; On-site; USD 60,000 - 100,000; Full time

Job summary

Ein führendes Unternehmen in der klinischen Forschung sucht einen Clinical Trials Quality Manager, der die Qualität und Konsistenz der Daten an verschiedenen Standorten überwacht. In dieser spannenden Rolle sind Sie verantwortlich für die Erstellung und Pflege von SOPs, die Durchführung interner Überprüfungen und die Schulung von Mitarbeitern. Sie arbeiten eng mit den Betriebsteams zusammen, um sicherzustellen, dass die besten Praktiken und Vorschriften eingehalten werden. Wenn Sie eine Leidenschaft für die Verbesserung der Gesundheitsversorgung haben und über umfangreiche Erfahrung in der klinischen Forschung verfügen, dann könnte dies die perfekte Gelegenheit für Sie sein.

Qualifications

• 5+ Jahre Erfahrung in der klinischen Forschung erforderlich.
• Zertifizierung von einer klinischen Forschungsorganisation bevorzugt.

Responsibilities

• Erstellung und Pflege von SOPs und Arbeitsanweisungen zur Einhaltung von Vorschriften.
• Durchführung interner Studienüberprüfungen zur Sicherstellung der Einhaltung von ICH-GCP.

Skills

Kommunikationsfähigkeiten

Aufmerksamkeit für Details

Teamarbeit

Organisationsfähigkeiten

Deduktives Denken

Education

Bachelor-Abschluss oder gleichwertig

Zertifizierung von einer klinischen Forschungsorganisation

Tools

MS Office

Job description

Overview

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and support services to broaden outreach and participation. Founded in 2018, our rapidly growing company operates 20+ sites across the US and Canada, with plans for further expansion.

The Role

The Clinical Trials Quality Manager is responsible for monitoring the quality and consistency of data and clinical operations at network clinical research sites throughout specific locations within the United States and Canada. This role ensures quality is integrated into all site processes and partners with Headlands Operations employees to verify quality outcomes. The role supports the company's success by reinforcing adherence to best practices, Good Clinical Practice, and relevant regulations.

We seek passionate employees committed to advancing healthcare and providing a safe, reliable, and compliant patient experience. Excellent communication and deductive reasoning skills are essential. Experience monitoring clinical research sites is preferred.

Responsibilities

1. Create and maintain SOPs, Work Instructions, and guidance at network and site levels, ensuring compliance with ICH-GCP and applicable regulations in the US and Canada.
2. Review and update existing SOPs and guidance to ensure compliance and consistency with network standards.
3. Support the development and delivery of training at the network and site levels in various formats.
4. Conduct internal study reviews to ensure adherence to ICH-GCP and regulations.
5. Prepare reports on review activities, categorize findings by risk, and propose corrective actions.
6. Collaborate with operations teams to address issues, implement corrective actions, and prevent recurrence.
7. Participate in quality investigations as needed.
8. Assist in developing, implementing, and tracking CAPAs within the region.
9. Assess and report risks impacting sites in the region.
10. Conduct quality reviews of external sites during M&A due diligence.
11. Support the integration of new sites into the network following the playbook.
12. Share best practices to maintain site inspection readiness.
13. Attend external audits and update internal leadership.
14. Track and support training of Headlands employees in the region.
15. Develop and deliver training materials for site staff.
16. Help site directors evaluate employee performance, especially during probation.
17. Participate in continuing education on quality initiatives, regulations, and industry practices.
18. Travel up to 30%, domestically and internationally.

Qualifications

1. Certification from a professional clinical research organization is preferred.
2. Bachelor’s degree or equivalent required; consideration given to candidates with an Associate’s degree and 5 years of experience.
3. Minimum of 5+ years in the clinical research industry.
4. Strong knowledge of federal and local regulations and GCP.
5. Adaptability from other cGXP environments.
6. Extreme attention to detail.
7. Effective communication and teamwork skills.
8. Strong organizational skills.
9. Ability to work independently or under supervision.
10. Proficiency in MS Office.
11. Ability to build rapport with colleagues and clients.