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Job #03101

About our client Our client is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases including cancer, inflammation, autoimmune and infectious diseases. Position Location Clinical Operations Manager Bloomsbury, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure project timelines, study files, site budget and report processes are maintained as per established procedures 2) Prepare clinical monitoring, site management plans and pharmacy plans including actions for study start-up, recruitment, monitoring and site management as well as quality data deliverables 3) Establish and monitor enrollment timelines for assigned studies 4) Train CRAs for assigned studies in study requirements (Investigator selection, feasibility assessments, initiation, monitoring, site management and closeout activities) 5) Coordinate ordering label review and packaging of drug supplies 6) Identify areas where resources or progress are not consistent with the operational plan 7) Help teams and management correct any divergence from time lines 8) Communicate up-to-date information regarding operational progress to all relevant interested parties 9) Liaise with Study Team members on operational issues, obtaining necessary input from Clinical Science, Data Management and others 10) Provide information for preparing study budgets and third party vendor agreements 11) Work with the Outsourcing Group to identify vendors and negotiate terms and conditions for performance of outsourcing tasks 12) Ensure adequate and timely performance by CRO/vendor 13) Review and approve all monitoring reports for assigned studies 14) Manage, track and report on overall site budgets at regular intervals 15) Drive and facilitate cross-departmental work and communications to ensure timely attainment of study milestones 16) Conduct operational team meetings at regular intervals with CRAs, Documentation Specialists and others as needed 17) Attend relevant symposia, conferences and scientific meetings 18) Ensure that company SOPs, GCPs and ICH guidelines are adhered to 19) Contribute to training activities and process improvement in Clinical Operations and participation in other tasks 20) Prepare study budgets and third party vendor agreements Requirements 1) BS or RN (advanced degree preferred) 2) Experience as a Lead CRA 3) In-depth knowledge of GCP and ICH guidelines 4) Expertise in CRO and vendor selection management