Regulatory Affairs Manager III

Integrated Resources Inc.; Fort Washington (PA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in workforce solutions is seeking a Clinical Quality Oversight Specialist. The successful candidate will be responsible for ensuring compliance in clinical trials and vendor oversight, requiring strong skills in project management, collaboration, and quality assurance. Applicants should have solid experience in regulatory compliance and the ability to monitor clinical trial execution effectively.

Qualifications

• Significant experience in vendor oversight activities for clinical trials.
• Demonstrated business acumen and effective workflow facilitation.
• Experience training or mentoring peers.

Responsibilities

• Develop and execute vendor oversight activities for clinical trials.
• Monitor risks and ensure compliance with GCP regulations.
• Manage significant quality issues and implement CAPAs.

Skills

Attention to Detail

Project Management

Communication

Collaboration

Team Performance Management

Enterprise Leadership

Job description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

1. Develops, maintains, and executes vendor oversight activities for assigned trials / indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
2. Monitors risks and mitigation during study execution.
3. Prepares periodic reports assessing critical to quality parameters.
4. Responds independently to GCP-related compliance inquiries from clinical team members and other departments on an ongoing basis.
5. Liaises with other members of Quality, as appropriate, to ensure alignment and consistency with guidance provided.
6. Develops and executes strategy to ensure inspection readiness for the vendor space, and provides support during sponsor-monitor inspections, as needed.
7. Manages escalation of significant quality issues per company policy and SOPs and in collaboration with stakeholders to ensure timely issue resolution.
8. Consults with appropriate business partners and peers within Quality to develop and implement CAPAs.
9. Critical skills needed to perform the job include enterprise leadership and facilitation, collaboration, attention to detail, significant experience and demonstrated business acumen, project management, communication, process management, and team performance management.
10. Making the complex simple and representing a true enterprise view are critical competencies.

Additional Responsibilities Include

• Consults independently on questions related to research quality and compliance from other departments and confers with other team staff, and other colleagues as needed, to ensure consistent interpretation of international regulations and policy.
• Participates in cross-functional or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.
• Trains or mentors peers and new staff as needed.

Additional Information

Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x219

Inc. 5000 – 2007-2015 (9 Years in a row)