Taylor Thomas Mazac

Taylor Thomas Mazac Email and Phone Number

Senior Clinical Trial Manager / Study Lead @ Mezzion
New York, New York, United States
Taylor Thomas Mazac's Location
New York, New York, United States, United States
Taylor Thomas Mazac's Contact Details

Taylor Thomas Mazac personal email

n/a
About Taylor Thomas Mazac

With over twelve years of experience in clinical research, including eight years in the biopharmaceutical industry, I am a personable professional who excels in challenging environments through collaboration and innovative approaches. I have extensive experience in global study and site management across multiple therapeutic areas, such as oncology and rare disease. Additionally, I have managed early development to late-phase global studies and have experience with FDA and EMA inspections.If you would like to learn more about my professional experience and interests, feel free to contact me through LinkedIn or at tmazac@gmail.com.

Taylor Thomas Mazac's Current Company Details
Mezzion

Mezzion

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Senior Clinical Trial Manager / Study Lead
New York, New York, United States
Website:
mezzion.com
Employees:
10
Taylor Thomas Mazac Work Experience Details
  • Mezzion
    Mezzion
    New York, New York, United States
  • Spruce Biosciences
    Senior Clinical Trial Manager / Study Lead
    Spruce Biosciences May 2023 - Present
    South San Francisco, California, Us
    • Lead the operations of multiple global clinical studies in early development and phases 2 and 3. • Led strategic partnerships for the company in the APAC region, totaling over $500 million.• Develop program timelines and forecasts for weekly presentations to senior leadership.• Participate in vendor selection, including vendor bid defenses and program budget, for a large, global phase 3 clinical study. • Lead vendor oversight for clinical research organizations (CROs), safety, central laboratory, and electronic data capture (EDC) system vendors. • Manage two direct reports, including allocation of resources. • Manage clinical program finances with study budgets, including negotiating and maintaining study vendor and site budgets. • Review and approve study invoices in alignment with the study budget. • Coordinate clinical study timelines to align with program milestones and objectives. • Lead company inspection readiness initiative and standard operating procedures (SOPs). • Develop study-specific systems for tracking key study activities and deliverables (e.g., risk tracking, vendor tracking, protocols, site quality, deviation tracking, eTMF). • Develop study manuals and plans, vendor management plans, procedures, master informed consent documents, and other study-related documents. • Responsible for the identification of potential investigator sites and oversight of the site evaluation process.
  • Global Blood Therapeutics
    Senior Clinical Trial Manager (Study Manager Ii)
    Global Blood Therapeutics Nov 2022 - May 2023
    South San Francisco, California, Us
    Post-GBT Pfizer Acquisition; Legacy-GBT• Manage and lead the operations of multiple clinical studies from study startup to closure. • Lead vendor oversight including clinical research organizations (CROs), safety, central lab, and electronic data capture (EDC) system vendors. • Manage clinical program finances with study budgets, including negotiating and maintaining study vendor and site budgets. • Review and approve study invoices in alignment with the study budget.• Coordinate clinical study timelines to align with program milestones and objectives. • Develop study-specific systems for tracking key study activities and deliverables (e.g., risk tracking, vendor tracking, protocols, site quality, deviation tracking, eTMF). • Develop study manuals and plans, vendor management plans, procedures, master informed consent documents, and other study-related documents. • Perform UAT testing for EDC eCRFs and other vendor platforms (e.g., IRT, ePRO).• Responsible for the identification of potential investigator sites and oversight of the site evaluation process. • Provide clinical monitoring oversight, including the review of metrics and reports to ensure compliance with the clinical monitoring plan.• Responsible for training study team members, external monitors, and study vendors.
  • Global Blood Therapeutics
    Clinical Operations / Clinical Trial Manager - Global Blood Therapeutics (Gbt)
    Global Blood Therapeutics Apr 2021 - Nov 2022
    South San Francisco, California, Us
    Global Blood Therapeutics • Manage and lead the operations of multiple clinical studies from study startup to closure. • Led vendor oversight including CROs, central lab, safety, and EDC vendors. • Managed clinical program finances with study budgets, including negotiating and maintaining study vendor and site budgets. • Coordinated clinical study timelines to align with program milestones and objectives. • Developed study-specific systems for tracking key study activities and deliverables (e.g., risk tracking, vendor tracking, protocols, site quality, deviation tracking). • Developed study manuals and plans, vendor management plans, procedures, master informed consent documents, and other study-related documents. • Performed UAT testing for EDC eCRFs and other vendor platforms (e.g., IRT, ePRO).• Oversaw the identification of investigator sites and oversight of the site evaluation process. • Provided clinical monitoring oversight, including the review of metrics and reports to ensure compliance with the clinical monitoring plan.
  • Global Blood Therapeutics
    Clinical Operations Consultant - Global Blood Therapeutics (Gbt)
    Global Blood Therapeutics Sep 2020 - Apr 2021
    South San Francisco, California, Us
    • Provide oversight and direction to study team members, including multiple vendors, for study deliverables.• Coordinate clinical study timelines to meet milestones; identifying and escalating issues that may impact study timelines and deliverables. • Provide clinical monitoring oversight, including the review of metrics and reports to ensure compliance with the clinical monitoring plan. • Oversee the drafting of study documents such as study plans, informed consents, vendor management plans, and study manuals and materials. • Responsible for clinical operations management of the externally sponsored research (ESR) program, which includes assisting in the development and alignment of program processes across multiple teams and key stakeholders.• Lead vendor project management on the development and implementation of a new study management system for the ESR program.
  • Icon Plc
    Clinical Research Associate / Site Manager Ii- Amgen
    Icon Plc Feb 2019 - Sep 2020
    Dublin, Ie
    Perform monitoring and site management activities to ensure the quality and integrity of the data collected in Amgen oncology-sponsored clinical trials.
  • Icon Plc
    Clinical Trial Manager - Bristol-Myers Squibb
    Icon Plc Dec 2017 - Feb 2019
    Dublin, Ie
    Responsible for managing multiple clinical sites across the United States for early development oncology clinical trials. Specifically, I am tasked with site startup and close-out activities, data management and continued review, including query resolution, eTMF review and maintenance, study vendor relations and management, and ensuring each site is complying with the Protocol and ICH-GCP guidelines.In addition to site management, I also assist with protocol management, including protocol revisions, global trial startup, maintenance and development of study trackers, subject randomization, biomarker and sample operations, and serving as coverage for the Clinical Scientist. Internal Committees & Achievements:• Current – ICF Site Management Expert (SME) Ambassador (for the Early Space)
  • Nyu Langone Health
    Senior Trial/Regulatory Specialist, Cancer Center Clinical Trials Office
    Nyu Langone Health Sep 2016 - Dec 2017
    New York, Ny, Us
    As a Senior Trial/Regulatory Specialist I was responsible for the management of site startup activities for the thoracic and phase I oncology programs, which includes, but not limited to FDA regulatory submissions; informed consent document (ICD) development; writing and amending ISR protocols; site trial coordination, and leading site initiation visits. Additionally, I was in charge of managing the startup of an oncolytic virus (mRNA) in combination with an IO study. This included required submissions (Appendix I-M) to the NIH for RAC registration and for Institutional Biosafety Committee (IBC) review and approval for all study sites. I also was heavily involved with the coordination of correlative samples.
  • Weill Cornell Medicine
    Quality Assurance Clinical Auditor & Dsmb Administrator (Oncology)
    Weill Cornell Medicine Aug 2015 - Oct 2016
    New York, Ny, Us
    Assisted in the development and implementation of the Office of Research Integrity Quality Assurance and Improvement Program, which included performing internal system quality assurance audits to evaluate trial conduct and protocol compliance with all applicable regulatory and ICH-GCP guidelines. Additionally, I served as the primary administrator for the oncology Data and Safety Monitoring Board (DSMB), which included the development of data and safety monitoring plans (DSMPs) and interim data and serious adverse event (SAE) review for all phases clinical trials. As part of the JCTO QAU, I also developed investigator-initiated, multi-site trial protocols, IND applications, monitoring plans, ICDs, and case report forms (CRFs).
  • Endpoint Outcomes
    Senior Research Associate
    Endpoint Outcomes Jan 2014 - Aug 2015
    As a Senior Research Associate I was responsible for collecting, coding and analyzing patient-level data, primarily to assist in the development of patient, clinician, and observer-reported outcomes.
  • Massachusetts General Hospital Cancer Center Protocol Office
    Clinical Research Associate / Coordinator
    Massachusetts General Hospital Cancer Center Protocol Office Apr 2013 - Jan 2014
    Boston, Ma, Us
    • Conducted data management (EDC) for multi-center site protocols to ensure all case report forms were complete and consistent.• Prepared trials for internal and sponsor audits that included reviewing and reconciling trial master files (TMFs) in accordance with ICH-Good Clinical Practice guidelines (ICH-GCP) and standard operating procedures (SOPs). • Handled sponsor protocol amendments, identifying appropriate changes to the site-specific informed consent document.• Oversaw the distribution, collection, and maintenance of all in-house protocol regulatory documents and associated files.• Developed and communicated protocol data management systems to study principal investigators and sponsors daily.
  • Boston Medical Center
    Research Assistant
    Boston Medical Center Apr 2012 - May 2013
    Boston, Ma, Us
    • Assist in the recruitment and screening of a large (N=320) randomized control trial.• Work closely with the Research Coordinator on daily recruitment functions including, PowerPoint presentations and updating and creating IRB documents.• Guide participant enrollment and informed consent process, managing all files and documentation.• Communicate with and advise participants on study activities with culturally competent measures.• Conduct research for and develop marketing and recruitment strategies for community outreach.• Perform quantitative data entry into a web-based software program (StudyTrax).• Assist with qualitative research projects in conducting interviews, thematic coding, and development of key concepts using qualitative data software (Atlas t.i.).
  • Massachusetts Department Of Public Health
    Office Of Hiv/Aids Client Services Intern
    Massachusetts Department Of Public Health Sep 2012 - Jan 2013
    Boston, Ma, Us
    • Worked closely with state contract managers in the Client Services Unit on the distribution of services within all Massachusetts Health Service Regions. • Developed a needs assessment on health disparities within services received by HIV/AIDS clients.
  • Texas A&M University
    Senior Research Assistant/Program Coordinator
    Texas A&M University Feb 2009 - Sep 2011
    College Station, Tx, Us
    • Managed all aspects of a P-60 NIH/NCMHHD funded project involving the creation of online professional development courses on health disparities and methods of cultural competency.• Oversaw day-to-day operations for project implementation and managed a research staff of five.• Collaborated with the Principle Investigator on study design, writing of grants and submission process, manuscript preparation, and development of study protocol (survey development).• Wrote research write-ups and project progress reports.• Managed all project communications and presentations.• Handled financial reimbursements and prepared and submitted Human Subjects Committee and IRB documents.
  • Md Anderson Cancer Center
    Research Intern
    Md Anderson Cancer Center Dec 2010 - Apr 2011
    Houston, Tx, Us
    • Participated in program development and implementation involving a P-20 NIH funded project.• Assisted project staff on the writing of peer-reviewed manuscripts. • Performed extensive literature reviews, collected background information for projects, and assisted with grant submissions.

Taylor Thomas Mazac Skills

Qualitative Research Public Health Program Evaluation Data Analysis Community Outreach Research Clinical Trials Clinical Research Grants Data Management Healthcare Statistics Grant Writing Oncology Regulatory Affairs Pharmaceutical Industry Clinical Monitoring Fda Gmp Sas Patient Reported Outcomes Good Clinical Practice Protocol Biotechnology

Taylor Thomas Mazac Education Details

  • Boston University
    Boston University
    Pharmaceutics And Drug Design; Epidemiology; Behavioral Science
  • Texas A&M University
    Texas A&M University
    General

Frequently Asked Questions about Taylor Thomas Mazac

What company does Taylor Thomas Mazac work for?

Taylor Thomas Mazac works for Mezzion

What is Taylor Thomas Mazac's role at the current company?

Taylor Thomas Mazac's current role is Senior Clinical Trial Manager / Study Lead.

What is Taylor Thomas Mazac's email address?

Taylor Thomas Mazac's email address is tm****@****amu.edu

What schools did Taylor Thomas Mazac attend?

Taylor Thomas Mazac attended Boston University, Texas A&m University.

What are some of Taylor Thomas Mazac's interests?

Taylor Thomas Mazac has interest in Healthcare Market Research, Lgbtq Health, Clinical Trials, Program Evaluation, Clinical Trial Design, Hiv/aids Prevention And Client Services, Sexual Health, Health Policy.

What skills is Taylor Thomas Mazac known for?

Taylor Thomas Mazac has skills like Qualitative Research, Public Health, Program Evaluation, Data Analysis, Community Outreach, Research, Clinical Trials, Clinical Research, Grants, Data Management, Healthcare, Statistics.

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