A result-driven professional with clinical project management experience in managing various stages of oncology clinical trials. Highly experienced in tumor assessment evaluation per WHO, RECIST 1.0, RECIST 1.1, CHESON and HALLEK criteria. Extensive knowledge in project planning and study document development in adherence to SOP, GCP, ICH, and FDA guidelines. Computer knowledge includes experience with Microsoft Excel, Word, Project, and Adobe Acrobat.
BioClinica, IncFebruary 2014 to CurrentClinical Project Manager Princeton, NJ
Managed multiple clinical trial phases of oncology trials; ensure regulatory compliance with FDA, ICH and GCPs; ensures non-regulatory compliance with study documents; developed project plans to meet study deliverables; analyzed and interpreted clinical results and data; and detailed, thorough clinical progress reports and summaries.
Identify potential risks through review of study reports.
Maintained sponsor site relations by hosting routine study team meetings and clearly communicating study status for all study deliverables and all potential risks that may adversely affect the study.
Responsible for managing the project scope of work and ensuring timelines, deliverables are met by both the sites and supporting departments Developed multiple study documents governing various scope of work during study-start up, steady-state, and study close-out.
Worked closely with radiologist and oncologist to ensure appropriate interpretation of image review is conducted per the protocol required oncology reading criteria Maintains the study budget and generation of monthly invoice tracking and identifying relevant change of scopes from original budget and contract.
Provide strategic leadership; establish scope of work, budgets, timelines, resources and priorities for studies Managed imaging component and regulatory submission deliverables for Phase III Clinical Trials Represent the company external sponsor meetings including sponsor audits and investigator meetings.
Responsible for providing finance and resource projections to ensure appropriate resources are allocated, as required, to meet project deliverables.
Resolve and/or escalate issues in a timely fashion, ensuring study management updated on all relevant project matters (e.g.
potential issues, anticipated significant variances in milestone dates and project budgets).
BioClinica, IncApril 2011 to February 2014Assistant Clinical Project Manager Princeton, NJ
Oversaw multiple clinical trials of varying phases; prioritized and met stringent timelines for clinical project deliverables.
Maintained sponsor site relations by hosting routine study team meetings and clearly communicating milestone for all study deliverable and all potential risks that may adversely affect the study.
Reviewed study requirements and response assessment criteria and collaborated with key project manager to develop study startup activities and associated documents (i.e.
charter, manual, data transfer plan, etc.).
Participated in internal audits, external audits, and preparation for FDA Audits Led internal Kick of Meetings and external Kick of Meetings as directed by Project Manager Streamlined project team operations by providing strategic leadership, clearly establishing scope of work, timelines, resources and priorities for studies alongside project manager.
Obtained extensive knowledge of RECIST 1.0 and RECIST 1.1 to analyze quality results of radiology and oncology assessment of data.
BioClinica, IncSeptember 2008 to April 2011Clinical Project Leader Princeton, NJ
Provide strategic leadership and managed daily activity and data flow from sites to internal customers.
Led project team in ensuring completion of all study start-up activities for domestic and international sites during the site activation phase of the study.
Monitored sites timely and accurate submission of subject scans.
Trained sites on protocols.
Effectually managed project coordinator's work load; organized daily workflow and assured critical timeline compliance Created open lines of communication by creating liaison plans for sites and sponsor, participating in routine teleconferences to review study status, reporting weekly study metrics.
Led team through detailed QC functions of source documents, reports, and daily media processes.
Participated in internal and sponsor audits.
Mentored and trained new project coordinators to perform their roles of a coordinator.
BioClinica, IncJuly 2007 to September 2008Clinical Project Coordinator Princeton, NJ
Directed site trainings; processed media; issued and resolved site queries.
Prepared images for QA reviews/audits image assessments in accordance to study protocol.
Organized, coordinated, and led protocol training of site monitors and clinical site personnel for clinical trials.
Education and Training
RUTGERS UNIVERSITY5 2007Bachelors of Arts: BiologyNew Brunswick, New JerseyBiology