Senior Manager, Clinical Operations in Woodcliff Lake, Bergen County, New Jersey

Description

Leads the cross-functional study team in managing one or more global clinical trials in Oncology, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and Eisai’s standard operating procedures.
Manages performance and development of assigned direct report(s).

Qualifications

BS/MS in relevant field
Experience in clinical operations methods and processes in industry setting required
Proven track record of leading international study teams, including CRO and vendor management and internal cross-functional collaborations to deliver high quality Oncology studies to time and budget. In depth understanding of current ICH/GCP guidelines.
Significant previous pharma industry experience in Oncology required, including awareness of current anti-tumour therapies, and be at ease with tools such as RECIST criteria for tumour assessment, NCI Common Toxicity Criteria. Experience in Immuno-Oncology an advantage.
Line management experience preferred.