Manager, Clinical Quality Oversight

ESSENTIAL FUNCTIONS


* 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

REQUIRED EDUCATION AND EXPERIENCE


* 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


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

Why CTI?


* Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.

We also value ongoing education and training through tuition reimbursement and a dedicated training department.


* Join an Award-Winnin...