Experience

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  KPS Life

  • Malvern, Pennsylvania, United States

  • Clinical Development Scientist

    • Nov 2022 - Present
    • Malvern, Pennsylvania, United States

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  Philips

  • Netherlands
  • Hospitals and Health Care
  • 700 & Above Employee

  • Senior Clinical Development Scientist

    • Aug 2021 - Oct 2022

    • Provided strategic input into clinical aspects related to the end to end (E2E) clinical development portfolio, from ideation through post marketed products• Worked closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as Key Opinion Leaders (KOL) and subject matter experts (SME’s)) stakeholders to ensure that the clinical safety and performance objectives will be met for all new products through non-clinical and clinical strategic input on product development and validation testing. • Responsible for professional collaboration with, investigators, IRB’s/EC’s, Regulatory Agencies, societies, and associations• Additional collaboration to support claims, reimbursement, health economic outcomes and / or market access.• Took a leading role to support the publication of study results. • Ensured appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer reviewed manuscripts, as assigned.• Lead and supported scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, including during sponsor regulatory inspections.

  • Clinical Development Scientist

    • May 2019 - Aug 2021

    • Participates in the development of global clinical strategy by working collaboratively with the clinical development, engineering, clinical and other cross-functional teams. • Paves the evidence generation pathway for new medical devices and non-medical general wellness devices• Provides clinical scientific input into clinical trial design and conduct.• Write clinical trial protocols for clinical investigations, clinical studies, consumer preference testing, consumer product testing, secondary data analysis and market research as needed throughout the product life cycle, during early exploration through advanced development, end of product life.• Ensures the highest quality of clinical study development and documentation to ensure compliance with GCPs, applicable regulatory requirements/standards and compliance to Philips Quality System Procedures• Assists in the collection, review, and analysis of data from participants/users based on questionnaires, apps, devices (images or other data) or other patient reported outcomes including medical/safety data reviews.

  • Clinical Contractor

    • Aug 2018 - May 2019

    • Assisted with preparation of required regulatory submissions to FDA• Ensured aligned communication between clinical, engineering, regulatory, and marketing to ensure field complaints were being properly documented, tracked and followed-up on to better inform product and software design for best practices• Initiated first in kind post-market clinical follow-up protocol designed to capture post-market data for EUMDR requirements• Completed start-up activities, including collection/ review of essential regulatory documents • Planned, scheduled, and performed monitoring visits, including site selection, site qualification, site initiation, site activation, routine monitoring, source verification, image data backup, image quality audit, and site closure visits. • Maintained frequent communication and regular face-to- face contact with investigators and clinical site staff to ensure ICH-GCP/protocol compliance and maximize subject accrual.• Reviewed safety reports and ensures the site is reporting adverse events appropriately and in a timely manner according to IRB requirements and Standard Operating Procedures.• Completed EDC system development, validation, verification, and implementation of eCRF processes

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  Delphinus Medical Technologies, Inc.

  • Sunnyvale, California

  • Clinical Research Associate III

    • Jul 2016 - Apr 2018
    • Sunnyvale, California

    •Collaborates with internal leadership, clinical site staff, and site investigators to drive successful execution of engineering test projects, clinical trials, and prospective case collection protocols•Proactively mitigates risks to meet established timelines and to ensure fulfillment of company recruitment / enrollment objectives set by Delphinus for clinical sites•Assists in site start-up activities including collection and review of essential regulatory documents to ensure sites are qualified for the study and there is sufficient documentation to support it•Maintains frequent communication and regular face-to- face contact with investigators and clinical site staff to ensure GCP/ICH/protocol compliance, and maximize subject accrual•Independently plans, schedules, and performs monitoring visits, including site selection, site qualification, site initiation, site activation, routine monitoring, source verification, image data backup, image quality audit, and site closure visits. •Conducts weekly internal meetings with site investigators and coordinators to discuss monitoring findings, action items, and site progress, as well as exchange pertinent information•Ensures all personnel at study sites are appropriately informed and trained. •Ensures timely query resolution through support of clinical sites•Reviews safety reports and ensures the site is reporting adverse events appropriately and in a timely manner according to IRB requirements and Standard Operating Procedures•Maintains ICH-GCP documentation for trial sites as stipulated•Assists with electronic data capture (EDC) system development, validation, verification, and implementation of eCRF processes, as requested by Clinical Affairs management•Assists with preparation of required regulatory submissions to FDA, as requested•Presents at and participates in Investigator Meetings, Clinical Advisory Board, trainings, professional conferences, and other clinical activities, as needed

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  Microbicide Trials Network

  • Pittsburgh

  • Protocol Development and Implementation Manager

    • Oct 2010 - Jun 2016
    • Pittsburgh

    • Developed over 35 HIV prevention IND clinical trials in a deadline-driven environment while collaborating with various stakeholders using diplomatic communication skills, and independent judgment to ensure the completion of a scientifically sound, fiscally protocol that is feasible for site implementation • Oversaw the implementation of over 20 MTN protocols to ensure they are following local and national regulations, network SOPs, and federal and global regulatory guidelines (i.e., ICH, GCP, Code of Federal Regulations, FDA, EMA, MCC, etc.).• Served as a network point of contact to study sponsors, scientific review bodies, and regulatory authorities, including the US DAIDS, FDA, CDC, IPM, Merck, CONRAD, etc.• Served as the Protocol Development Manager for domestic and international study sites responding to queries about the practical interpretation of study requirements. • Employed the use of various applications and programming to ensure protocols are generated in the most efficient manner and contain the most up-to-date data from peer-reviewed journals, resulting in documents of the highest caliber.• Communicated with scientific leadership to carry out the strategic agenda of the MTN through the creation of protocols, Manual of Procedures and Standard Operating Procedures that maintain the highest standards in both ethics and science.• Prioritized, coordinated and synthesized contributions from study sponsors, investigators, study sites, community-based organizations, MTN Network Laboratory for the NIH/NIAID, US Division of AIDS (DAIDS), US Food and Drug Authority (FDA), Centers for Disease Control (CDC), and agencies.• Oversaw the output and professional development of all staffed Protocol and Regulatory Specialists.