Wilmington, North Carolina, United States
A detail-oriented Project Leader focusing on a proactive approach to project delivery for all phases of a clinical trial. Experienced in the Clinical research and pharmaceutical industry with additional years of experience in a clinical laboratory environment. Experiences include but not limited to cross functional oversight and support throughout phases I-IV, multi-center, double-blind, randomized and observer-blind, expanded access programs, and peri/post approval studies in a variety of patient populations. In addition, building a foundation of trust amongst all stakeholders through focused efforts on vital project deliverables and financial interests.
Fulfilling the Study Project Lead role by providing overall cross-functional leadership on clinical studies to achieve operational excellence and deliver projects on time, to budget, to the highest quality, compliant with ICH GCP, and that meet client expectations. Maintain responsibility of Project Leadership activities such as risk management, milestone tracking & delivery, financial oversight, maintaining relationship with client, and ensuring the overall development and success of the study. In addition, building a foundation of trust amongst all stakeholders through focused efforts on vital project deliverables and financial interests. Project Lead role activities include, but are not limited to: •Manage projects throughout start-up, maintenance, and close out. Adapting dynamically to changes throughout the life of the study. •Lead meetings with appropriate stakeholders regarding relevant study activities, including but not limited to cross functional internal calls, milestone planning, risk review, and financial meetings. •Offer guidance and support to the development of project team members related to project activities and professional development. •Track and report on the status of study milestones, financial health, achievements, and risks to senior leadership and clients. •Provide oversight to functional leaders and external teams to ensure the timely delivery of project milestones. •Oversee the development of integrated project plans for each functional area of assigned studies. •Maintain ownership of study planning tools. •Provide cross functional oversight and support during regulatory inspections. •Ensure that changes in scope and budget updates are made according to client expectations. •Review and approve study invoices within agreed timelines.
Provides overall cross-functional leadership on clinical studies to achieve operational excellence and deliver projects on time, to budget, to the highest quality, compliant with ICH GCP, and that meet client expectations. Maintain responsibility of Project Leadership activities such as risk management, milestone tracking & delivery, financial oversight, maintaining relationship with client, and ensuring the overall development and success of the study. In addition, building a foundation of trust amongst all stakeholders through focused efforts on vital project deliverables and financial interests.
Provides the overall cross-functional leadership of clinical trials as well as the project teams to achieve operational excellence and deliver projects on time, to budget, to the highest quality, compliant with ICH-GCP, and that meet client expectations. Key accountabilities include but are not limited to maintaining responsibility for Project Leader tasks and deliverables according to SOPs on assigned projects, performing initial and ongoing risk management, manage and ensure first time quality on project deliverables, develop and manage client relationship at a study level, understand and own the project profit and loss through a variety of financial oversight tasks, manage the cross-functional project team, and appropriately represent the Project Leadership function internally as well as externally in a variety of meetings and presentations.
Drive and own a sub-set of project-specific activities as directed by the Project Lead to support overall delivery of the project in addition to leading regional Project Management activities. Coordinated problem solving efforts including management of risks, development of contingencies, and resolution of issues with internal and external stakeholders. Primary tasks included but were not limited to providing oversight to functional leads, leading financial reconciliation efforts, vendor invoice review/approval, assist with development and implementation of budget change orders, monthly financial unit forecasting/actualization, draft/update project plans, lead/coordinate team meetings (internal/client), track study milestones, and liaising with functional leads on key study deliverables.
Managed clinical sites participating in assigned study protocol as traveling CRA. Worked in accordance with relevant regulations, SOPs, and study specific guidelines; to ensure patient safety and data integrity always. Clinical monitoring tasks included but not limited to: managing/supporting sites as a CRA according to study protocol and monitoring plan, subject eDiary system review/support, vendor data reconciliation, as well as source data verification/review and query management utilizing Medidata Rave EDC. Areas of monitoring activities included site start-up, site initiation, maintenance, database lock, and site/study termination. Experienced in studies utilizing the Risk Based Monitoring approach. Therapeutic experience in Digestive (Irritable Bowel Syndrome) and Immunology (Vaccine and Anti-Viral Treatments).
Worked directly on location with assigned clinical sites and work in accordance with relevant regulations, SOPs, and study specific guidelines; to ensure patient safety and data integrity always. Clinical monitoring tasks included, but are not limited to: managing/supporting site activities according to study protocol, training of site personnel, timely resolution of site issues, document collection, source data review, source data verification, IP accountability, review IP compliance and ensuring timely/high quality data entry at a site level.
PAREXEL’s monitor working directly on location with assigned clinical sites and work in accordance with relevant regulations, SOPs, and study specific guidelines; to ensure patient safety and data integrity always. Clinical monitoring tasks include, but are not limited to: managing/supporting site activities according to study protocol, training of site personnel, timely resolution of site issues, document collection, source data review, source data verification, IP accountability, review IP compliance and ensuring timely/high quality data entry at a site level. Phases of monitoring activities include site start-up, site initiation, ongoing monitoring, database lock, site termination, and study closure. Therapeutic experience in Endocrine/Metabolic Diseases: Diabetes Mellitus Type II.
Act as PAREXEL’s remote contact with assigned clinical sites and to work in accordance with relevant regulations, SOPs, and study specific guidelines; to ensure patient safety and data integrity always. Remote clinical monitoring tasks include, but are not limited to: managing/supporting site activities according to study protocol, training of site personnel, timely resolution of site issues, document collection, remote source data verification, and ensuring timely/high quality data entry at a site level. Phases of monitoring activities include site start-up, site initiation, ongoing monitoring, database lock, site termination, and study closure.
Tasks include, but are not limited to: perform analysis on several clinical trials; check directors’ reports for accuracy; perform corrective action in response to audit reports; maintain a detailed inventory of laboratory reagents; sustain a high level of focus and attention to detail while performing repetitive tasks; process and analyze samples according to GCP, GLP, CAP, CLIA, and FDA standards; validate new procedures and reagents. SNP Microarray Perform laboratory procedures in accordance with the standard operating procedures of the Cytogenetics Microarray laboratory. Procedures including the preparation of patient samples, DNA extraction, PCR amplification, DNA purification and gene chip analysis to perform SNP microarray testing. Data collected is used to assist in preparation of diagnostic reports by a Director or Pathologist. Fluorescence in Situ Hybridization Perform laboratory procedures in accordance with the standard operating procedures of the cytogenetics FISH laboratory. Procedures including the preparation of blood, bone marrow, and tissue samples for the application of fluorescent probes to target chromosome regions followed by microscopic analysis. Data collected is used to assist in preparation of diagnostic reports by a Director or Pathologist.