Samantha Krivensky, MBA, MPH

Experience

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  Columbia University Medical Center

  Sept 2014 - Apr 2016

  Research Assistant

  Executed 3 longitudinal studies examining impact of various interventions (e.g. aerobic exercise, dietary intervention) on cognitive functioning in adults while following regulatory guidelines.• Organized research visits for 5-7 subjects per week and expertly guided them through each protocol procedure. • Recruited 20+ participants per week by performing phone screens, reviewing medical and psychiatric background, and designating study eligibility.

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  Massachusetts General Hospital

  Apr 2016 - Jul 2021

  Managed project start up, organization, deliverables, and budgets for 20+ protocols, bringing sound project management, clinical research expertise, and regulatory guidance while supervising a team of 6 research assistants. Reported to the Director of the unit and liaised across both internal and external departments.• Led clinical and imaging research teams (~15 members) on process improvements and team deliverables; provided insight on areas of improvement and oversaw execution.• Transferred lab (~30 members) to remote work during COVID-19 pandemic and developed hybrid research protocols to continue data collection while ensuring participant and team safety.• Introduced development of internal procedural manuals to establish continuity of information and documentation of decision making. Show less Coordinated implementation of 6 longitudinal neuroimaging projects (250+ subjects enrolled) following both healthy individuals and those with neurodegenerative diseases.• Facilitated Institutional Review Board submission process by preparing protocol applications, protocol amendments, safety reports, adverse event reports and other required documents for all protocols.• Maintained lab-wide regulatory documents for all protocols per NIH and MGH guidelines.• Supervised recruitment, evaluation, and hiring of new research project staff including orientation and training. Show less

  • Clinical Research Project Manager

    Apr 2018 - Jul 2021

  • Senior Clinical Research Coordinator

    Apr 2017 - Apr 2018

  • Clinical Research Coordinator

    Apr 2016 - Apr 2017
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  Novartis Institutes for BioMedical Research (NIBR)

  Jun 2022 - Aug 2022

  Translational Clinical Oncology Graduate Intern

  Strengthened understanding of early development clinical trial lifecycle by working closely with the cross functional team and observing all levels of clinical operations, including the planning and implementation of trials.• Summer Deliverable: conducted extensive research and interviews on the FDA initiative ‘Project Optimus’ and presented to the larger TCO team (40+ members) on dose optimization in early phase oncology trials.

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  Questrom School of Business, Boston University

  Jan 2023 - May 2023

  Graduate Teaching Assistant - Biotech/Pharma Innovation

  Course: Driving Health Sector InnovationSupervising Faculty: Dr. Rena Conti

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  Takeda

  Jul 2023 - Jul 2024

  Senior Manager, Emerging Priorities & Innovation

  Ensured seamless coordination, execution, oversight, and successful delivery of projects aimed at innovating within the clinical trial ecosystem, while maintaining alignment with the Takeda's strategy, priorities, and goals.• Partnered with the Head of EP&I, directors, internal cross-functional stakeholders, and vendors to drive the strategic vision of innovative clinical trial solutions forward.• Assisted in achieving change management objectives related to valuable clinical trial optimizations that benefit both patients and the organization.• Evaluated potential technologies and vendors for value, risks, and strategic fit through research and insight gathering. Show less

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  Novartis

  Jan 2025 - now

  Senior Clinical Sciences Trial Leader, Neuroscience