Nadia Bracken

Nadia Bracken Email and Phone Number

Senior Manager, Centralized and Risk Based Monitoring @ Summit Therapeutics, Inc.
California, United States
Nadia Bracken's Location
Redwood City, California, United States, United States
Nadia Bracken's Contact Details
About Nadia Bracken

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

Nadia Bracken's Current Company Details
Summit Therapeutics, Inc.

Summit Therapeutics, Inc.

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Senior Manager, Centralized and Risk Based Monitoring
California, United States
Nadia Bracken Work Experience Details
  • Summit Therapeutics, Inc.
    Senior Manager, Centralized And Risk Based Monitoring
    Summit Therapeutics, Inc.
    California, United States
  • Biomea Fusion
    Clinical Trial Manager (Leukemia Program)
    Biomea Fusion May 2023 - Present
    Downtown Redwood City, California, Us
    Phase 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.
  • Good View Clinical, Llc
    Clinical Operations Consultant
    Good View Clinical, Llc Jan 2019 - Dec 2023
    San Francisco, Calfornia, Us
    Adjuvance 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.
  • Medidata Solutions
    Clinical Operations Advisor (Rbqm), Senior Consultant
    Medidata Solutions Jun 2021 - Aug 2022
    New York, Ny, Us
    Subject 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.
  • Nektar Therapeutics
    Sr. Clinical Trial Manager
    Nektar Therapeutics Apr 2017 - Oct 2018
    San Francisco, California, Us
    Oversee 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.
  • Gilead Sciences
    Clinical Trials Manager
    Gilead Sciences Jun 2014 - Apr 2017
    Foster City, Ca, Us
    HIV clinical trial management for fixed-dose combination therapy in virologically suppressed adolescents.
  • Biotie Therapies, Inc.
    Clinical Trial Manager
    Biotie Therapies, Inc. Nov 2011 - Jun 2014
    Turku, Fi
    Manage 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.
  • Fibrogen
    Clinical Research Associate Ii
    Fibrogen Sep 2010 - Nov 2011
    San Francisco, Ca, Us
    Site management for three domestic Phase II anemia correction trials and oversight of contract regional CRAs.
  • Contract Research Organizations (Various)
    Regional Clinical Research Associate
    Contract Research Organizations (Various) Nov 2007 - Sep 2010
    Regional 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.
  • Life Science & Biotech (Various)
    Clinical Research (Associate Level)
    Life Science & Biotech (Various) Jul 2005 - Nov 2007
    In-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
  • Biogen Idec
    Therapy Support Coordinator
    Biogen Idec Mar 2003 - Dec 2004
    Cambridge, Ma, Us

Nadia Bracken Skills

Clinical Trials Gcp Cro Edc Clinical Research Clinical Development Clinical Data Management Ctms Fda Protocol Ich Gcp Clinical Operations Regulatory Submissions Drug Development Data Management Clinical Monitoring Oncology Clinical Trial Management Clinical Site Monitoring Therapeutic Areas Hematology Clinical Study Design Crf Design Microsoft Excel Infectious Diseases Good Clinical Practice Cra Management Clinical Site Management Subject Recruitment Site Initiation Medidata Cro Management Electronic Data Capture Project Management Phase Ii Phase Iii Cardiovascular Disease Cns Disorders Pulmonary Diseases Patient Recruitment Pharmaceutical Industry Microsoft Word Sharepoint

Nadia Bracken Education Details

  • North Carolina State University
    North Carolina State University
    Bachelor Of Science - Bs
  • University Of California, Santa Cruz
    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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