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As a seasoned Leader of Clinical Data Management with a proven track record of delivering high-quality, compliant clinical trial data across the pharmaceutical, biotech, and medical device sectors, I am excited to bring my expertise to a company. My unique blend of leadership, technical acumen, and commitment to innovation aligns seamlessly with your organization’s goals.Throughout my career, I have excelled in addressing critical challenges in Clinical Data Management (CDM), including:Confidence in CRO Data Management: I have consistently ensured accuracy and compliance by leading high-performing teams and overseeing CROs with budgets exceeding $5 million, as seen in my tenure at Pionyr Immunotherapeutics and Immune Design Corp.Project Management Integration: By spearheading data operations and implementing robust DMPs, I have enhanced the efficiency of cross-functional teams and integrated diverse data sources to drive successful study outcomes.Expertise in MedDRA and WHODrug Coding: I have guided teams in coding and licensing these essential dictionaries, ensuring compliance and seamless database operations.RFP Crafting and Vendor Oversight: With a deep understanding of EDC, IRT, and related systems, I have successfully managed RFP processes and led vendor evaluations for cutting-edge technology solutions.I am eager to bring this expertise to your team, fostering operational excellence and innovation in clinical data management. Enclosed, you will find my CV, which further details my accomplishments and technical proficiency in platforms such as Medidata Rave™, Veeva Vault™, and CDISC SDTM standards.
Datapro Solutions Llc
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Senior Lead Data ManagerDatapro Solutions Llc Jan 2024 - Present• Spearheaded the development of comprehensive Data Management Plans for small to medium biotech clinical studies.• Led data quality through meticulous planning and adherence to Good Clinical Practice (GCP) standards.• Expertly oversaw and selected Contract Research Organizations (CROs) to support study data management.• Developed proficiency in Electronic Data Capture (EDC) systems for efficient data collection and analysis.
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Senior Director, Data ManagementPionyr Immunotherapeutics Aug 2020 - Dec 2023South San Francisco, California, UsTherapeutic Areas: Oncology Solid Tumor| Immunotherapy● Spearheaded all Clinical Data Management (CDM) planning, and operational activities within and outside of the organization providing long-term strategic leadership of the CDM unit supporting several drug development programs (PY314, PY159, and PY265) resulting in outside strategic partnership funding.● Promoted to direct and oversee Clinical Data Managers (Full Time/Contractor) as well as Clinical SAS programmers (Contractor) in project support and deliverables.● Established Biomarkers Data Transfer Agreement (DTA) process with external lab partners, CDM SOPs, and template in coordination with Pionyr QA, Bioanalytical, and IT for clinical study programs.● Oversight CROs budgets (PPD and Advanced Clinical) (> 5 million) and vendors to ensure they are aligned with scope and compliance expectations based on outsourced studies and company objectives.● Completed the successful Database lock of PY314 Part A (12/28/22), the first clinical database locked in the organization. -
Associate Director Of Clinical Data Management| Clinical Operations & Data ManagementImmune Design Corp., A Wholly-Owned Subsidiary Of Merck & Co., Inc. 2018 - 2019Therapeutic Areas: Oncology Solid Tumor, Non-Hodgkin Lymphoma vaccine● Shepherd all Clinical Data Management (CDM) planning and operational activities in relation to the company’s CMB305, G100 vaccine programs for various targets against solid tumors, and Non-Hodgkin’s Lymphoma Phase I/IB/II studies for future NDA registration of Phase III clinical trials.● Drove and evaluated new EDC clinical database platforms for the acquisition of Immune Design URL/Software license.● Oversaw CROs (Medpace & Advanced Clinical) vendors to ensure they are aligned with scope and compliance expectations based on outsourced studies and company objectives.
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Director Of Clinical Data Management, Consultant | Clinical Trial OperationsAgensys, Inc., An Affilate Of Astellas Pharma Inc. 2016 - 2018Therapeutic Areas: Oncology Solid Tumors, Lymphoid Malignancies, Acute Myeloid Leukemia● Governed all Clinical Data Management (CDM), planning and operational activities for the company’s Antibody drug conjugates (ADC) programs for various targets against solid tumors, lymphoma and leukemia: Phase I/IB/II studies partnered with Astellas U.S. Pharma for NDA registration of Phase III clinical trials. ● Managed staffing of the CDM department and led the design implementation of clinical processes that aligned with parent company, Astellas Pharma US.● Led vendor and technology bids evaluation, qualification, and selection of CRO partners.● Oversaw CRO (Syneos & LabConnect) vendor to ensure they are aligned with scope and compliance expectations based on outsourced studies and company objectives.
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Study Data Manager, Consultant | Clinical Trial OperationsGenentech 2016 - 2016South San Francisco, California, UsTherapeutic Area: Oncology Solid TumorsLed CDM study team and oversaw all build, conduct and close activities for one or more studies Phase I studies using data management strategies that yielded positive business results. -
Principal Clinical Data Manager, ConsultantPuma Biotechnology 2013 - 2015Los Angeles, Ca, UsTherapeutic Experience: Oncology (Breast Cancer)Served as study Lead Data Manager responsible for Phase III study of Women with Early Stage HER-2 Breast Cancer Study (3,300 subjects/460 sites), with successful Medidata Rave database lock on March 6, 2015. -
Lead Data ManagerAirxpanders Jun 2012 - Nov 2012Therapeutic Area: Oncology Breast Cancer DeviceManaged data collection of 510K device and transfer process between clinical sites, CRAs, Sponsor and CRO, advising CRO to establish database build to closely match CDISC standards.
David Edghill Skills
David Edghill Education Details
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The George Washington University School Of Medicine And Health SciencesHealth Sciences And Clinical Research -
Jacksonville UniversityBusiness Management/ Spanish
Frequently Asked Questions about David Edghill
What company does David Edghill work for?
David Edghill works for Datapro Solutions Llc
What is David Edghill's role at the current company?
David Edghill's current role is Senior Director | Associate Director | Lead Data Manager | Expert in Clinical Data Management within Biotech, Pharma, & Medical Device Industries – Advancing Healthcare through CDM Analysis & Database Lock.
What is David Edghill's email address?
David Edghill's email address is da****@****ign.com
What is David Edghill's direct phone number?
David Edghill's direct phone number is +150953*****
What schools did David Edghill attend?
David Edghill attended The George Washington University School Of Medicine And Health Sciences, Jacksonville University.
What are some of David Edghill's interests?
David Edghill has interest in Hiking, Weightlifting, Running, Mountain Biking.
What skills is David Edghill known for?
David Edghill has skills like Edc, Clinical Data Management, Clinical Trials, Pharmaceutical Industry, Clinical Development, Biotechnology, Medical Devices, 21 Cfr Part 11, Sas Programming, Clinical Operations, Ctms, Fda.
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