Jill D

Clinical Research


Clinical Research


Hazlet, NJ

Education Level:


Will Relocate:



SUMMARY: * rn, bsn, cpm, * Over 28 years of Clinical Research experience * Respiratory, Ophthalmology, Oncology, Infectious Disease, Cardiovascular, CNS and Gastrointestinal * Phase I, II and III experiences * 14 years of Clinical Trial/Project Management experience * 4 years of field monitoring experience * 14 years of experience providing oversight to CTAs and CRAs PurDue PharmA July 2017 - present Sr Clinical Project Manager Clinical Operations Data Analytics and Compliance * Accountable for all aspects of CRO oversight and vendor management for assigned trials and responsible for driving them to complete their activities in accordance with any contracted terms. * Serve as the operational lead and primary point of contact for cross-functional teams (both internal and external) to ensure the effective operational delivery of all study milestones from study start up, through conduct and close out. * Proactively evaluates and communicates the probability and impact of risks develops quality and risk management plans for performance and ensures this is integrated into the plan for oversight and management of project deliverables * Deliver against and contribute to operational quality goals & objectives. Accountable for ensuring inspection readiness across the CRO and internal study teams as well as compliance and quality of assigned studies and key deliverables such as ICFs, Monitoring plans, CRO and site training, etc. * Responsible for audit responses and development of CAPAs specific to Clinical Operations * Review protocols and advise on the operational feasibility and planning involved in the execution and conduct of the protocol. * Responsible for analyzing data trends, KPIs/metrics, and applying lessons learned to drive proactive planning, oversight and quality management of clinical trials. * Report study progress against project plan via study status reports (and reporting trends to Project Team and Clinical Operational Research and Development (CRD) leadership) * Manage budget utilization per study (and potentially per product). * Oversee drug supply requirements and accountability from pre-study through completion. * Asset Team member for complex and/or large projects, acting with a high degree of independence and autonomy. * Mentors CPMS and other study team members. * Focus on Phases I and II


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