Arlene Lee Email and Phone Number
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Arlene Lee personal email
Arlene Lee phone numbers
As the Director of Product Management for Data Quality and Risk Management solutions at Medidata, I use my extensive industry background to drive innovation in data quality and centralized monitoring systems. Before joining Medidata, I accumulated over 20 years of experience in the pharmaceutical industry, including more than 17 years in Clinical Data Management and Centralized Monitoring within CRO, pharmaceutical, and biotech sectors. I have led the execution of Phase I–IV clinical trials across multiple therapeutic areas, with a particular focus on oncology and vaccines. I have also played a key role in establishing data management practices and advancing data quality solutions for global studies. My expertise includes:•Driving strategic initiatives and fostering innovation to enhance data quality and risk management solutions.•Leading and mentoring high-performing teams to achieve organizational goals and deliver exceptional results.•Establishing and optimizing operational processes through effective resource management, timeline adherence, and risk-based quality management (RBQM) strategies.•Building strong, collaborative relationships with clients, colleagues, and executive leadership to drive successful outcomes.•Managing regulatory inspections (FDA, MHRA) and ensuring compliance with industry standards, including ICH GCPs, GLPs, and GMPs.•Delivering impactful presentations at audits, bid defenses, investigator meetings, and industry conferences.•Leveraging expertise in financial oversight, budgeting, and resource allocation to maximize efficiency and performance.•Bringing a comprehensive understanding of the drug development lifecycle and therapeutic area expertise, particularly in oncology and vaccines.Therapeutic experience includes:•Oncology: Solid tumors, lymphoma, gliomas, neuroblastoma, renal cell carcinoma, melanoma•Vaccines: SARS-CoV-2 (COVID-19), Respiratory Syncytial Virus (RSV), Influenza•Age-Associated Memory Impairment and Alzheimer’s disease•Osteoporosis•Diabetes Mellitus Types 1 and 2•Cardiovascular Diseases•Medical Devices•Ophthalmology•Infectious Disease
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Director Of Product Management (Data Quality And Risk Management Solutions)Medidata Solutions Jul 2023 - PresentNew York, Ny, UsTransform Data Management and Data Quality Oversight in the clinical research industry through innovations in product development. Support cross-product engineering teams to define and deliver world-class technology to market. -
Associate Director, Clinical Data ManagementDay One Biopharmaceuticals May 2022 - Jul 2023Brisbane, California, UsAccountable for Clinical Data for Day One-sponsored trials and CRO vendor oversight. Responsible for end-to-end clinical data management activities and contributed to the company's long term data generation and management strategy. -
Senior Manager, Centralized Monitoring - Data AnalyticsPpd Mar 2021 - Apr 2022Wilmington, Nc, UsResponsible for startup activities that drove strategy and planning for key clients. Provided supervisory functions, managed resources and ensured operational execution of projects to time, quality and cost expectations. -
Manager, Data AnalyticsPpd Jan 2020 - Mar 2021Wilmington, Nc, UsCentralized Monitoring: Project oversight and supervisory responsibilities for Centralized Monitoring Analysts.
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Manager, Clinical Data ManagementSdc (Statistics & Data Corporation) Apr 2019 - Jan 2020Tempe, Arizona, Us -
Manager, Clinical Data ManagementPpd Apr 2018 - Apr 2019Wilmington, Nc, UsProvided people management functions for a team within the Clinical Data Management department and represented CDM in business development meetings.
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Principal Clinical Data ManagerPpd Oct 2016 - Apr 2018Wilmington, Nc, UsCDM Study Manager with study oversight responsibilities including resourcing and budgets.
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Lead Clinical Data ManagerUbc - An Express Scripts Company Jun 2014 - Oct 2016Blue Bell, Pa, Us -
Asst Clinical Data Manager | Assoc Data Team Lead | Sr. Clinical Data CoordinatorQuintiles 2006 - 2014Durham, North Carolina, Us -
Quality Assurance Coordinator | Laboratory Calibration Group Leader | ChemistPfizer 1992 - 2000New York, New York, Us
Arlene Lee Skills
Arlene Lee Education Details
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University Of Missouri-ColumbiaChemistry
Frequently Asked Questions about Arlene Lee
What company does Arlene Lee work for?
Arlene Lee works for Medidata Solutions
What is Arlene Lee's role at the current company?
Arlene Lee's current role is Director, Data Quality and Risk Management Solutions @ Medidata | RBQM | Clinical Data Management.
What is Arlene Lee's email address?
Arlene Lee's email address is ar****@****pdi.com
What is Arlene Lee's direct phone number?
Arlene Lee's direct phone number is +121559*****
What schools did Arlene Lee attend?
Arlene Lee attended University Of Missouri-Columbia.
What skills is Arlene Lee known for?
Arlene Lee has skills like Data Management, Edc, Cro, Gcp, Clinical Data Management, Oncology, Quality Assurance, Ich Gcp, Oracle Clinical, Pharmaceutical Industry, Clinical Trials, 21 Cfr Part 11.
Who are Arlene Lee's colleagues?
Arlene Lee's colleagues are Kristen Dannecker, Maris Van Dyke, Nihanth Kota, Neha Y., Daniel King, Musashi Kudo, Denise Yun T..
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