Manager, Clinical Quality Oversight

Join The CTI Team•Covington, KY

10d•Hybrid

About The Position

The Manager, Clinical Quality Oversight will maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions. This role provides regulatory compliance guidance and quality improvement consultation to internal and external customers, ensuring global alignment. Responsibilities include conducting protocol risk reviews, developing trial-level QA Oversight Plans aligned with RBQM principles, trial phase, and identified critical-to-quality (CtQ) cross-functional risks. The role involves monitoring trial-level QTLs, KPIs, and communicating results to the trial team. Additionally, it includes conducting TMF and CTQ risk-based SOP compliance assessments and targeted deep-dive evaluations based on identified quality signals and trends. Communication of compliance assessment outcomes, escalating significant risks, and designing/delivering advanced training on QA topics are key aspects. The role also involves independent trend analysis of quality events and protocol deviations, reviewing Major/Critical CAPAs, attending Project Management meetings, leading QA to QA governance meetings, and participating in regulatory inspections. Collaboration with the internal auditing function for trial-specific CTQ processes and review of RBQM risks for inspection readiness are also included. The role focuses on maintaining continuous inspection readiness and developing sponsor questionnaires to measure program effectiveness. Hosting sponsor qualification/requalification audits and mentoring junior employees are also part of the responsibilities.

Requirements

Bachelor’s degree or equivalent relevant experience
5+ years of experience in life sciences, CRO, or similar industry
Advanced knowledge of GCP guidelines, clinical trial operations, and core clinical research processes.
Proficiency in the English language

Nice To Haves

Certification in auditing (RQAP, ASQ) or other quality-related certification is preferred

Responsibilities

Maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions.
Provide regulatory compliance guidance and quality improvement consult to internal and external customers, ensuring global alignment.
Conduct protocol risk reviews and develop trial level QA Oversight Plans aligned with RBQM principles, trial phase, and identified critical-to-quality (CtQ) cross-functional risks.
Monitor trial-level QTLs, KPIs, and communicate results to the trial team.
Conduct TMF and CTQ risk-based SOP compliance assessments and targeted deep-dive evaluations based on identified quality signals and trends.
Communicate compliance assessment outcomes clearly and effectively, verbally and in writing, escalating significant compliance risks to project team leadership, QA leadership, CTI executive management, and sponsor representatives as appropriate.
Design and deliver advanced training to trial teams on QA topics tailored to address compliance challenges identified during snapshot and deep dive compliance assessments, audits, and inspections.
Independent trend analysis of quality events and protocol deviations, separate from the trial team review, to detect emerging or unrecognized trends.
Review Major/Critical CAPAs and provide strategic guidance for action implementation, and monitor effectiveness checks.
Attend Project Management-led team meetings.
Lead or attend Client QA to QA governance touchpoint meetings.
Participate in regulatory inspections and mock inspections to support inspection readiness.
Work with CTI internal auditing function to target trial-specific CTQ processes for the internal audit schedule, as applicable.
Review RBQM risks when applicable for completeness and inspection readiness.
Maintain continuous inspection readiness through alignment of global pre-inspection requests with controlled quality documentation.
Develop and implement periodic sponsor questionnaires to measure overall approval, satisfaction, and perceptions of program effectiveness.
Host sponsor qualification and requalification audits.
Mentor and lead junior-level employees as assigned.