I enjoy reading, hiking in the beautiful Colorado mountains with my dogs and spouse and spending time with my community
Stephanie Monza
Denver,CO
Summary
Program management professional with history of driving projects to successful completion. Skilled in strategic planning, risk management, and resource allocation. Known for fostering team collaboration and delivering results in dynamic environments. Proven expertise in optimizing processes and aligning initiatives with organizational objectives.
Overview
22
22
years of professional experience
Work History
Principal Clinical Research Scientist
Medtronic
01.2022 - Current
- Operating Unit: Cardiac Ablation Solutions
- Responsible for the program management of 100+ global physician led research projects
- Assessed program effectiveness using rigorous evaluation methods, identifying strengths and weaknesses while guiding necessary adjustments leading to a 50% increase in successful physician research applications
- Optimized resource allocation by identifying synergies across multiple clinical programs, leading to an increase in the annual budget from $400k to $2Million in 2 Years
- Spearheaded interdisciplinary collaborations, leveraging diverse expertise to successfully develop a robust and attainable clinical strategy.
- Developed and maintained strong relationships with key stakeholders, ensuring successful collaboration on clinical initiatives.
Senior Clinical Research Specialist
Medtronic
03.2020 - 01.2022
- Operating Unit: Patient Monitoring and Respiratory Solutions
- Responsible for the comprehensive cross-functional oversight and day-to-day operations of a three IDE complex global clinical studies, ensuring alignment with and training on ICH/GCP guideline and applicable regulations, while managing a $5 million dollar clinical study budget
- Collaborated with regulatory affairs and R&D to prepare detailed and timely progress reports for sponsors, stakeholders, and regulatory authorities keeping them apprised of key developments in ongoing trials.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
Senior Clinical Research Specialist
Medtronic
05.2018 - 03.2020
- Operating Unit: Surgical Innovations
- Leveraged deep therapeutic area expertise to guide the clinical strategy and study design process for an FDA designated Breakthrough device
- Organized and facilitated advisory board meetings, engaging KOLs to gather critical insights, feedback, and guidance on clinical development of an oncological combination Breakthrough device
- Responsible for leading the clinical pre-submission discussions with the FDA to obtain alignment on the clinical development strategy and regulatory pathway
- Responsible for the comprehensive cross-functional oversight and day-to-day operations of a pediatric IDE global clinical study, ensuring internal and external training on ICH/GCP guideline, study protocol and applicable regulations
Clinical Research Specialist
Medtronic
03.2017 - 05.2018
- Operating Unit: Surgical Innovations
- Directly responsible for the management and oversight of clinical trial sites, ensuring adherence to study protocols, ICH/GCP guidelines, and all applicable regulations
- Conducted review of clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Associate Clinical Research Specialist
Advanced Ablation Solutions
12.2015 - 03.2017
- Operating Unit: Advanced Ablation Solutions
- Played a pivotal role in the development of the clinical strategy for an IDE study, leveraging in-depth therapeutic area expertise and a deep understanding of the competitive landscape
- Assessed the site's infrastructure, personnel, procedures, and capabilities to ensure alignment with the study protocol, ICH/GCP guidelines, and all applicable regulations
Senior Clinical Research Coordinator
Medical Device - Advanced Ablation Solutions
05.2015 - 12.2015
- Operating Unit: Advanced Ablation Solutions
- Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
- Improved patient recruitment by developing and implementing targeted outreach strategies.
- Fostered a positive working environment for research staff through regular team-building activities and ongoing professional development opportunities.
Certified Clinical Research Coordinator
Children's Hospital Colorado
05.2013 - 05.2015
- Department: Pulmonary Medicine
- Provided guidance and support to the sleep medicine fellows in the development of their research protocols, ensuring alignment with scientific and ethical standards
- Served as the primary point of contact for the IRB, including preparing and submitting research protocols, while responding to any queries or requests for additional information in a timely and thorough manner
- Pulmonary Medicine
Clinical Research Coordinator
Children's Hospital Colorado
05.2013 - 05.2015
- Department: Research Institute
- Responsible for the overall coordination and execution of sponsored clinical research studies, serving as the central point of contact between the sponsor, investigators, and research team
- Facilitated the initiation and implementation of the sponsored studies, ensuring adherence to the study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulations
- Managed the participant recruitment, screening, enrollment, and retention processes, implementing effective strategies to meet the study enrollment targets
Registered Polysomnographic Technologist
National Jewish Health
09.2009 - 09.2010
Polysomnographic Technologist
Alexian Brothers Medical Center
09.2004 - 09.2009
Polysomnographic Technologist
Northwestern Memorial Hospital
07.2002 - 07.2003
Education
Master of Science - Biomedicine and Business
Drexel University
Philadelphia, PA10.2024
Bachelor of Science - Biology, Minor in Chemistry
Hardin-Simmons University
Abilene, TX01.2002
Skills
- Stakeholder & Physician Engagement
- Clinical Study Report Writing
- Scientific Presentations
- Protocol Development
- Strategic Planning
- Process Improvement
- Decision-Making
- Clinical Strategy Development & Execution
- Clinical Study Execution
- Clinical Study Monitoring Cardiac SME
- Medical Science Liaison
- Program Management
Accomplishments
- Global Excellence Award: Celebrating extraordinary work that makes a positive impact of healthcare.
- Move with Speed and Decisiveness: Improves how work is accomplished; Generates momentum; Makes the right call.
- Deliver Results the Right Way: Takes preventive measures and models ethical behavior; Ensures accountability; Gets it done.
Interests
Timeline
Principal Clinical Research Scientist
Medtronic
01.2022 - Current
Senior Clinical Research Specialist
Medtronic
03.2020 - 01.2022
Senior Clinical Research Specialist
Medtronic
05.2018 - 03.2020
Clinical Research Specialist
Medtronic
03.2017 - 05.2018
Associate Clinical Research Specialist
Advanced Ablation Solutions
12.2015 - 03.2017
Senior Clinical Research Coordinator
Medical Device - Advanced Ablation Solutions
05.2015 - 12.2015
Certified Clinical Research Coordinator
Children's Hospital Colorado
05.2013 - 05.2015
Clinical Research Coordinator
Children's Hospital Colorado
05.2013 - 05.2015
Registered Polysomnographic Technologist
National Jewish Health
09.2009 - 09.2010
Polysomnographic Technologist
Alexian Brothers Medical Center
09.2004 - 09.2009
Polysomnographic Technologist
Northwestern Memorial Hospital
07.2002 - 07.2003
Bachelor of Science - Biology, Minor in Chemistry
Hardin-Simmons University
Master of Science - Biomedicine and Business
Drexel University
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