Natalie Senderowicz Email & Phone Number

Boston, Massachusetts, United States

-Assist the Biosample Operations Managers with the conduct of the sample management aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are on time, within budget, and consistent with program/company biosample strategy-Collaborate with vendors across multiple studies to coordinate initial kit and sample collection supply shipments to study sites prior to Site Initiation Visits (SIVs) and to replenish kits during study conduct-Track biosamples across multiple studies by reviewing inventory reports from central and analytical laboratories and reconciling with Electronic Data Capture (EDC)-Assist with the development and review of sample-related documents, including clinical protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), laboratory manuals, vendor budgets, and vendor invoices-Assist with the development of lab-related Standard Operating Procedures (SOPs) and other internal documents including sample management plans and inspection-readiness tools

Boston, Massachusetts, United States

Boston, Massachusetts, United States

-Reviewed ICFs, clinical protocols, and operational study plans, including Communications Plan, Project Start-up Plan, Trial Master File (TMF) Plan, Contract Research Organization (CRO) Oversight Plan, Satellite Site Oversight Plan, Edit Check Plan, Project Management Plan, Clinical Management Plan, Integrated Data Review Plan, and File Review Plan-Recorded minutes for vendor, study team and site teleconferences, distributed for team review and consolidated comments into one document prior to submitting for finalization and distribution to the study team-Performed User Acceptance Testing (UAT), generating findings for edit checks and optimizing EDC design-Assisted with the oversight of document quality within the TMF for inspection-readiness according to study milestones

Cambridge, Massachusetts

-Co-led the authorship, review, and management of regulatory submissions for a novel epigenetic cancer drug for Food and Drug Administration (FDA) and European Medicines Agency (EMA) submission -Reviewed and edited regulatory documents, including Drug Safety Update Report (DSUR), Investigator’s Brochure (IB), and a Phase 3 protocol synopsis-Performed regulatory intelligence activities, including assessment of competitive landscape, to inform regulatory strategy

-Reviewed and performed quality checks on DSUR, IB, and Summary of Clinical Safety (SCS) and Efficacy (SCE) for FDA submission-Examined source files and documents to migrate, synthesize, format, and validate tables, listings, and figures (TLFs)

Greater Boston Area

-Prepared a literature review to inform a potential study regarding limited literacy, stigma, and mental illness in Australia-Disseminated qualitative focus group data to pilot an effective adult education course within a mental health facility in Boston-Attended coworkers' practice presentations and provided feedback for clarification

Greater Boston Area

-Condensed 30 investor analyst reports into 2-page company profile for Board of Directors-Aggregated safety data from an ovarian cancer clinical trial for Chief Medical Officer-Dispatched agenda items, sent out PowerPoint slides, and drafted minutes for weekly Program Team meetings -Investigated discrepancies between clinical trial protocols and informed consent forms

Greater Boston Area

-Co-wrote the protocol for an emotional recognition study involving eye calibration, cognitive tests, and computer-programmed tasks-Directed over 40 participants through emotion regulation and recognition studies and processed physiological and cognitive data-Organized, edited, and critiqued a dissertation containing an emotion recognition study

Waltham, Ma

-Compared the toxicity profile of docetaxel, a chemotherapy agent, to a nanoparticle formulation of docetaxel, informing the clinical team’s assessment of treatment combinations for an area of unmet need-Assessed the competitive landscape of drugs approved for ovarian cancer and their combinability with a nanoparticle formulation of a topo-I inhibitor, enabling evidence-based customization of business development presentations

Boston, Ma

-Sorted and counted incoming mail for the renowned Nurses'​ Health Study-Examined questionnaires for completeness and accuracy-Transcribed subjects' write-in responses into numeric codes on questionnaires

Cambridge, Ma

-Conducted community outreach research and communication-Assisted with the coordination of press and publicity-Updated donor profiles in database and created mailing lists

Bethesda, Md

-Recruited healthy subjects for a transcranial magnetic stimulation study in order to investigate premotor cortex changes after a computer game-Attended schizophrenia presentations and learned methods of evaluating psychiatric patients