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.

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.

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.

-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.

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.

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