Manager, Clinical Quality Oversight

CTI Clinical Trial and Consulting Services•Covington, KY

11d•Hybrid

About The Position

This role is responsible for maintaining advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions. The Manager, Clinical Quality Oversight will provide regulatory compliance guidance and quality improvement consultation to internal and external customers, ensuring global alignment. This position involves conducting protocol risk reviews, developing trial-level QA Oversight Plans aligned with RBQM principles, and monitoring trial-level QTLs and KPIs. The role also includes conducting TMF and CTQ SOP compliance assessments, communicating compliance outcomes, and designing and delivering advanced training on QA topics. Additionally, the role involves independent trend analysis of quality events, reviewing CAPAs, attending project meetings, leading QA governance meetings, participating in regulatory inspections, and working with the internal auditing function. The Manager will also review RBQM risks, maintain inspection readiness, develop sponsor questionnaires, host sponsor audits, and mentor junior employees.

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