Emily Winters Email and Phone Number
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Highly-energetic, creative, and collaborative biotechnology professional and science enthusiast with expertise in gene therapy and rare disease clinical research. Demonstrated track record of delivering high-qulaity clinical trials in fast paced environments. Strong project management, analytic, and communication skills. Recognized for mastering progressive responsibilities throughout my career. Passionate about the biotechnology industry and bringing novel therapeutics to the market.
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Associate Director Clinical OperationsVerismo Therapeutics Apr 2024 - PresentPhiladelphia, Pennsylvania, Us
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Associate Director Clinical OperationsPassage Bio Mar 2023 - Mar 2024Philadelphia, Pennsylvania, Us -
Senior Manager Of Clinical OperationsPassage Bio Nov 2021 - Mar 2023Philadelphia, Pennsylvania, Us
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Manager Of Clinical OperationsPassage Bio Oct 2020 - Nov 2021Philadelphia, Pennsylvania, Us
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Clinical Study ManagerSpark Therapeutics, Inc. Jan 2018 - Oct 2020Philadelphia, Pa, Us-Drafts and reviews Informed Consent Forms, contract, and budgets, in collaboration with the clinical trial study lead, Legal Department, external vendors, and other necessary functions.-Ensures accurate preparation of all regulatory and study-specific documents.-Primary contact for investigative site personnel and external vendors for clinical trial protocol execution.-Develops and presents training materials on clinical trial implementation to internal and external collaborators.-Participates in departmental, clinical sub-team, and product development strategy team meetings.-Conducts quality control review of documents and assists Clinical Quality Assurance during inspections and audits.-Leads review of protocol deviations and site issues to identify trends and mitigate potential operational problems. -
Clinical Trial AssociateSpark Therapeutics, Inc. Jun 2017 - Jan 2018Philadelphia, Pa, Us-Supported the Hematology Clinical Operations team in executing high-quality clinical trials.-Developed and maintained trackers for study startup, sample management, and other trial activities for study oversight.-Wrote and edited study-related plans, templates, work instructions, and newsletters. Facilitated review of internal documents by cross-functional teams.-Led efforts to identify, contact, and assess feasibility of clinical trial sites for future trials. Organized cross-functional team input into clinical trial site selection.-Served as a point-of-contact for Contract Research Organizations, clinical sites, and external service providers for issues that arose during study startup and execution. Escalate issues to appropriate level as needed.-Trained on ICH-GCP principals and industry guidelines
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Oncology Alliance InternAstrazeneca Jan 2017 - Apr 2017Cambridge, Cambridgeshire, Gb-Developed metrics to assess the quality of data generated from external collaborations in late-stage Oncology clinical trials to make strategic partnering decisions.-Generated reports using IMPACT, Microsoft Excel, and internal databases to evaluate external engagement results.-Collaborated cross-functionally to analyze data in a way that benefits multiple key stakeholders.-Determined how to best present information in order to drive business discussions based on stakeholders’ needs. -
Research SpecialistUniversity Of Pennsylvania Jun 2014 - Jul 2016Philadelphia, Pa, Us-Designed, implemented, and presented data on experiments using immunology techniques and CRISPR technology in the translational research laboratory of Dr. James Riley to develop chimeric antigen receptor (CAR) T-cell immunotherapies.-Collaborated with a biotechnology company to validate the efficacy of a novel cell culture media for growth of primary human T cells.-Provided a complete customer service experience for researchers ordering human immune cells by delivering technical and order support, improving customer relations, and designing user manuals to increase clarity in the ordering process.Techniques: Cell culture, DNA cloning, in vitro transcription, Lipofectamine virus transfection, CRISPR, Ficoll-paque gradient separation, multi-color panel flow cytometry.
Emily Winters Skills
Emily Winters Education Details
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Georgetown UniversityBiotechnology -
Hamilton CollegeMinor: Theater
Frequently Asked Questions about Emily Winters
What company does Emily Winters work for?
Emily Winters works for Verismo Therapeutics
What is Emily Winters's role at the current company?
Emily Winters's current role is Associate Director, Clinical Operations.
What is Emily Winters's email address?
Emily Winters's email address is em****@****ktx.com
What is Emily Winters's direct phone number?
Emily Winters's direct phone number is +1 888-772*****
What schools did Emily Winters attend?
Emily Winters attended Georgetown University, Hamilton College.
What skills is Emily Winters known for?
Emily Winters has skills like Organization, Research, Teamwork, Pcr, Databases, Microsoft Excel, Gel Electrophoresis, Dna Extraction, Data Entry, Spss, Leadership, Powerpoint.
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