Nadia Bracken Email and Phone Number
Nadia Bracken work email
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Nadia Bracken personal email
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18+ years Clinical Operations leadership and Project Manager. I apply a background in data management fundamentals to efficiently collaborate and deliver novel therapies for clinical research patients.Unwavering professional integrity and commitment to excellence in Clinical Protocol Design and Implementation, Developing Presentations, Site/Monitor/Vendor Oversight, Project/Budget Management, GCP Oversight & Regulatory Compliance, and Documentation plus Operational Data Analysis.Extensive life sciences background in clinical trial design, management, and CRO collaboration. Clinical Research strategic account portfolio manager experienced in client services for clinical software. Proven ability to predict issues at early stages of a project and elevate data-driven insights to mitigate risks.I am a creative person who works effectively with teams to address challenges around trial setup, documentation, accruals, patient recruitment, clinical trial inspections, and data quality readiness. Colleagues appreciate that I am extremely organized when interacting with eClinical technologies to measure and report progress. As a regular speaker at global drug development events like DIA and SCOPE and programs hosted by ACRP and SoCRA, I am a champion for improving how we work in this industry.In the margin, just for fun...👩🏻💻 I facilitate conversations with clinical researchers around the world at GCP Cafe virtual coffee networking events. ☕️ These interactive sessions equip clinical researchers with the tools, expertise, and knowledge necessary to advance important clinical developments and patient-centric operations for clinical trials. #showyourmug #clindividual #GCPcafe
Summit Therapeutics, Inc.
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Senior Manager, Centralized And Risk Based MonitoringSummit Therapeutics, Inc.California, United States -
Clinical Trial Manager (Leukemia Program)Biomea Fusion May 2023 - PresentDowntown Redwood City, California, UsPhase 1 First-in-Human Clinical Trial Management for Leukemia drug development program. Responsible and accountable for managing operational activities for clinical trial vendors, and cross-functional teams (i.e. Data Management, Pharmacovigilance, GCP Quality Assurance, etc.). Ensure study milestones for clinical site activations, accruals, and monitoring/risk/safety oversight are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. Manage activities of junior staff members in Clinical Operations. -
Clinical Operations ConsultantGood View Clinical, Llc Jan 2019 - Dec 2023San Francisco, Calfornia, UsAdjuvance Technologies (Project Management & Clinical Operations): Advance lead vaccine technology platform to clinical stage. Project Manager for technical operations, supply chain, and clinical operations reporting to CEO. Supporting the Chief Medical Officer, operationalized first-in-human proof of concept clinical trial in Australia.Clinical Operations Consulting (oncology solid-tumor/various): Created study-level dashboards and internal team portals in Microsoft Sharepoint Sites and Smartsheet to track feasibility effort, CRO/vendor oversight activity, and operational metrics; Facilitated continuous study-level trial risk assessments to identify potential regional/site issues via Cluepoints key risk indicators and other proprietary systems and data quality listings review. -
Clinical Operations Advisor (Rbqm), Senior ConsultantMedidata Solutions Jun 2021 - Aug 2022New York, Ny, UsSubject Matter Expert (SME) role in Professional Services focused on consulting and advising Medidata clients/partners during and after implementation of Medidata Clinical Cloud RBQM Products on a Unified Platform. Leveraging 15+ years experience from Clinical Operations leadership roles in Sponsors and CROs related to strategic initiatives for clinical trial management, oversight of operations, and risk identification/mitigation. Supporting advancement of clinical development focusing on products and services for Risk Based Quality Management and process management. -
Sr. Clinical Trial ManagerNektar Therapeutics Apr 2017 - Oct 2018San Francisco, California, UsOversee data currency and manage technology vendors for immuno-oncology clinical trials through effective relationships with cross-functional study management team, CROs, and key study stakeholders. -
Clinical Trials ManagerGilead Sciences Jun 2014 - Apr 2017Foster City, Ca, UsHIV clinical trial management for fixed-dose combination therapy in virologically suppressed adolescents. -
Clinical Trial ManagerBiotie Therapies, Inc. Nov 2011 - Jun 2014Turku, FiManage all operational aspects of single-center Phase I and multi-center International Phase II CNS trials and CROs in site identification/qualification, trial conduct, developing study tools and procedures, and data review through final study report generation in accordance with corporate timelines. -
Clinical Research Associate IiFibrogen Sep 2010 - Nov 2011San Francisco, Ca, UsSite management for three domestic Phase II anemia correction trials and oversight of contract regional CRAs. -
Regional Clinical Research AssociateContract Research Organizations (Various) Nov 2007 - Sep 2010Regional CRA on assignment as Functional Service Provider (FSP) Clinical Research Site Manager for Pfizer clinical studies. Supported multiple protocols and programs (CNS: Restless Legs Syndrome, Smoking Cessation, Depression) as needed and provided clinical site monitoring and management.Regional CRA based out of San Francisco for a large CRO. Managed multiple protocols (Anti-coagulation/Thrombosis, Dyslipidemia, Rheumatoid Arthritis, and Pulmonary: Lung Transplant) for various sponsor companies. Traveled regionally and conducted monitoring visits in US and Canada.
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Clinical Research (Associate Level)Life Science & Biotech (Various) Jul 2005 - Nov 2007In-house Clinical Research Associate Aug 2006 - Nov 2007Managed Phase 1 trials and inspection readiness activities for global Phase 3 studies. Clinical Data Manager Jul 2005 - Aug 2006
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Therapy Support CoordinatorBiogen Idec Mar 2003 - Dec 2004Cambridge, Ma, Us
Nadia Bracken Skills
Nadia Bracken Education Details
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North Carolina State UniversityBachelor Of Science - Bs -
University Of California, Santa Cruz
Frequently Asked Questions about Nadia Bracken
What company does Nadia Bracken work for?
Nadia Bracken works for Summit Therapeutics, Inc.
What is Nadia Bracken's role at the current company?
Nadia Bracken's current role is Senior Manager, Centralized and Risk Based Monitoring.
What is Nadia Bracken's email address?
Nadia Bracken's email address is nb****@****sol.com
What schools did Nadia Bracken attend?
Nadia Bracken attended North Carolina State University, University Of California, Santa Cruz.
What are some of Nadia Bracken's interests?
Nadia Bracken has interest in Photography, Travel, Reading.
What skills is Nadia Bracken known for?
Nadia Bracken has skills like Clinical Trials, Gcp, Cro, Edc, Clinical Research, Clinical Development, Clinical Data Management, Ctms, Fda, Protocol, Ich Gcp, Clinical Operations.
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