Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Publications
Timeline
Generic

Amador Rosales

Denver,CO

Summary

Clinical Trial Manager with 10 years of clinical research experience, including 6 years in direct trial management. Proven track record of overseeing complex studies across global sites in both the pharmaceutical industry and academia. Award winning leader recognized for timely delivery in study start-up and collaboration efforts in vendor management. Passionate and deeply committed to driving innovation and improving healthcare outcomes by leveraging my expertise.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Clinical Trial Manager

ICON -Embedded with Amgen
06.2023 - Current
  • Helped lead the strategic planning and execution of a global Phase III clinical trial spanning 252 sites, ensuring alignment with study protocols, regulatory requirements, and key timelines.
  • Collaborated with cross-functional teams to manage study lifecycles, delivering consistent, high-quality outcomes while mitigating risks.
  • Help spearhead vendor partnerships (IRT, recruitment, imaging) to enhance recruitment and data management processes, delivering study milestones efficiently.
  • Proactively addressed and resolved study-specific challenges to ensure seamless operational flow and project success.
  • Played a pivotal role in study start-up, from document creation to site activation and planning, ensuring all study milestones are met.
  • Delivered comprehensive study health reports to the global team, providing strategic insights and tracking progress against key deliverables.
  • Championed study quality by overseeing the development and completion of CST and site learning modules, ensuring adherence to regulatory and procedural standards.
  • Managed the preparation and maintenance of inspection-ready documents and metrics, driving compliance with SOPs and work instructions to ensure operational excellence throughout the study lifecycle.
  • Participated in leadership meetings to ensure patient safety and accurate data collection is being captured.

Project Manager

ICON -Embedded with Takeda
10.2021 - 06.2023
  • Served as a project manager to assist with implementing and managing governances with clinical partners to help with: sponsor and supplier communications, successful accomplishment of study milestones, quality assurance events, and issue escalations.
  • Led the time-sensitive global communications for central laboratories across Takeda that led to improved site decision making.
  • Led the collaboration and managed the input of leadership to help create a new service line for Takeda.
  • Helped develop governance metrics to provide oversight of vendor performance, quality, and impact on Takeda Programs.
  • Co-developed visuals with leadership to inform and drive organizational supplier strategy for Takeda leading to more effective decision making.
  • Worked with internal and external stakeholders and served as a point of contact for central laboratories and clinical technology partners (IRT, Imaging, eCOA, ECG, EDC) to ensure suppliers performed at a high level.
  • Collaborated with study teams, functional leads, procurement, quality assurance, and leadership to help facilitate successful submission of supplier selection for new clinical research studies leading to higher quality partnerships with vendors.
  • Managed a cross-functional leadership forum used to oversee supplier selection by reviewing supplier submissions, tracking leadership approvals, and distributed awards to study teams.

Project Manager

Northwestern University
07.2020 - 10.2021
  • Provided scientific & project management leadership to help plan, track, and achieve milestones for 9 endocrine and metabolism cross functional research studies.
  • Led all clinical study operations from study start-up to close out: IRB study submissions and modifications, preparation of clinical documents (research protocols, consent forms, study data forms); helped with study budgets, adverse event reporting, prepared for audits, and maintenance of study documents.
  • Led the collaboration of researchers, data collection and build of a user-design diabetes device that aimed to be patented and manufactured.
  • Led all team meetings, distributed agendas and minutes, reported study status, and led a diverse team of designer and manufacturer directors, mechanical engineers, physicians, consultants, and research staff across four departments.
  • Initiated, developed, and structured all study site operations: data collection databases, clinical supplies, technology, patient recruitment, and point of contacts for research studies, and helped analyze data.
  • Completed study pilot to strategize recruitment and retention during COVID-19: analyzed electronic health records, helped design operational plans within the hospital, collaborated with healthcare staff, recruited all patients, and contributed to manuscripts and publishings.
  • Presented ongoing study methods and findings to department heads for feedback and collaboration on future grants.

Project Coordinator

Northwestern University
06.2017 - 07.2020
  • Led researcher collaborations, site setup, and data collection setup, for a new researcher at Northwestern that led to successful researcher collaborations and new grants, and the successful completion of six research studies.
  • Managed and coordinated all research study operations to ensure all six distinct cancer research studies are completed on time and within budget.
  • Led all clinical study operations from study start-up to close out: IRB study submissions and modifications, preparation of clinical documents (research protocols, consent forms, study data forms); helped with study budgets and grants, adverse event reporting, prepared for audits, and maintenance of study documents.
  • Led study recruitment and retention efforts, led community efforts to aid recruitment, and designed recruitment materials.
  • Helped lead focus groups with cancer survivors, completed literature reviews, and contributed to manuscripts.
  • Led research team meetings, captured CTT minutes, reported status updates, tracked and presented data, and distributed and ensured task completion of action items.
  • Managed external relationships with stakeholders and the team dynamics of seven co-investigators, nine doctoral students, one research assistant, and one intern.
  • Hired new staff, coordinated all on-boarding processes, performed all staff training for specific applications, and prepared all research staff performance evaluations.

Research Assistant

Northwestern University
05.2016 - 06.2017
  • Determined patient eligibility for a cancer/oncology study, extracted patient data from medical records (EMR), consented and enrolled study participants.
  • Collected and helped prepare over 120 blood and saliva samples.
  • Collaborated and communicated with 20 team members (psychologists, physicians, nurses, and researchers) to carry out the research functions across three research sites in Chicago.
  • Provided project updates and functional goals towards achieving project milestones at research team meetings.

Research Assistant Intern

Northwestern University
05.2015 - 05.2016

Education

M.S. - Health Communications

Northwestern University
01.2020

B.S. - Biological Sciences

Southern Illinois University
01.2015

Skills

  • Clinical trial management
  • Project management
  • Vendor management
  • Governance
  • Issue escalations
  • Study-startup
  • Study maintenance
  • Vendor selection
  • Company communications
  • Eclinical
  • EDC
  • Spotfire
  • TMF
  • IRT
  • IRB submissions
  • Quality assurance
  • Imaging
  • Clinical trial systems
  • Team building
  • Budget management
  • Oncology
  • Endocrinology

Certification

Project Management, Google, 01/01/21

Accomplishments

  • Contributor to research of IMDELLTRA which was featured on TIME Magazine as 'Best Inventions of 2024', 01/01/24
  • Awarded with 2024 ICON Inspire Award for collaboration in achieving Tier 3 enrollment goal 2 months early, 01/01/24
  • Awarded with 2024 ICON Inspire Award for successful FSE ahead of schedule for study start-up, 01/01/24

Publications

  • Understanding Facilitators and Barriers in the Hospital Discharge Processes of Newly Prescribed Insulin: A Mixed-Methods Study, Cheong M Yu, MD, Alice Lu, BS, MPH, Emilie Touma, BA, Pamela Wax, MD, MBA, Amador Rosales, MS, Colleen M StudySmyrniotis, MSN, CDCES, Daniel H Schneider, MS, Jane L Holl, MD, MPH, Amisha Wallia, MD, Journal of the Endocrine Society, 05/03/21, 5, Supplement_1
  • Application of Health Services Outcome Research Approaches to Refine Pragmatic Trial Design during COVID-19, Pamela Wax, Rebeca Khorzad, Cheong M Yu, Emilie K. Touma, Amador Rosales, Grace Prince, Kasey Coyne, S. Bailey, Teresa Pollack, C. Barnard, R. Ackermann, J. Holl, A. Wallia, Diabetes, 06/01/21, 70, Supplement_1, 826-P

Timeline

Clinical Trial Manager

ICON -Embedded with Amgen
06.2023 - Current

Project Manager

ICON -Embedded with Takeda
10.2021 - 06.2023

Project Manager

Northwestern University
07.2020 - 10.2021

Project Coordinator

Northwestern University
06.2017 - 07.2020

Research Assistant

Northwestern University
05.2016 - 06.2017

Research Assistant Intern

Northwestern University
05.2015 - 05.2016

B.S. - Biological Sciences

Southern Illinois University

M.S. - Health Communications

Northwestern University

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