Heather Dwyer
Cambridge,Canada
Summary
Experienced Clinical Project Manager with a strong history in research project management, recognized for significantly improving study quality and operational efficiency at Axiom Real-Time Metrics. Demonstrated expertise in leading multi-site studies and obtaining federal funding, complemented by advanced skills in GCP and data management. Proven ability to communicate effectively and foster collaboration within diverse teams. Aiming to leverage this expertise to drive innovative clinical research initiatives.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Part-Time Martial Arts Instructor
Boundless Martial Arts
Cambridge & Kitchener, Ontario
01.2025 - Current
- Instruct children and adults in: Goju Ryu karate, kobudō, and Brazilian jiujitsu.
- Build and maintain positive personal relationships with students and families, serve as a role model and character educator, and prioritize safety by supervising classes closely.
- Support tournaments and competitions to motivate students to improve their techniques.
Part-Time Professor
Conestoga College
Kitchener, Ontario
09.2023 - Current
- Conduct comprehensive onsite and remote instruction in 2 Ontario Graduate Certificate programs: Clinical Research and Regulatory Affairs.
- Foster critical thinking skills.
- Assist with developing course modules within the Clinical Research Graduate Certificate program.
- Maintain student engagement through creative subject delivery and learning activities.
Clinical Project Manager
Axiom Real-Time Metrics
Mississauga, Ontario
10.2023 - 12.2024
- Global clinical project management of studies in depression and COVID-19.
- Managed 23 sites in 2 countries.
- Qualified eight new sites for activation.
- Developed Clinical Monitoring, Study Start-up, and Deviation Management plans.
- Developed a study budget and renegotiated the contract changes for four sites.
- Revised two study protocols and coordinated subsequent regulatory submissions.
- Managed site and client communication, eTMF management, and site-level payments.
- Revised department SOPs and forms to enhance quality, efficiency, and consistency in executing critical start-up processes.
- Performed remote site monitoring and reviewed CRA trip and expense reports.
- Managed CRAs, vendors, and clinical trial assistants.
Senior Research Manager Pre-Clinical & Clinical Projects
Kapoose Creek Bio Corp.
Vancouver, Canada
08.2022 - 03.2023
- Supported product development by managing several preclinical and clinical projects in pain management and concussion therapy.
- Identified and contracted a vendor for non-clinical testing.
- Coordinated the third-party execution of two preclinical In-Vivo studies and one In-Vitro study.
- Developed and executed a retrospective clinical study protocol with a contracted site.
- Successfully co-authored two federal funding applications, securing support from Natural Products Canada and the National Research Council (NRC).
- Monitored progress against project timelines, budget constraints, and quality standards.
- Provided technical expertise in clinical regulatory and ethics management and data collection and management.
Clinical Research Consultant
14517105 Canada Inc.
Cambridge, Ontario
05.2020 - 08.2022
- Managed preclinical and clinical projects in anxiety, substance use disorders, and pain management for academic researchers and small biotech companies.
- Protocol development and ethics management through a central IRB for one multi-site and two single-site projects.
- Successfully led the design and execution of a single-arm, open-label, pharmacokinetic study, from protocol development through sample analysis.
- Led five retrospective studies for controlled prescription products in development.
Part-Time Graduate Student Research Trainee
McMaster University
Hamilton, Ontario
09.2019 - 09.2021
- Coordinated and supported investigator-initiated clinical projects in anxiety, depression, ADHD, PTSD, and substance use disorders.
- Led the development of one protocol, eCRF design, and user acceptance testing for two online studies.
- Unblinded IP management for a controlled substance study.
- Supported funding applications, budget management, site selection, and IP procurement for one project.
Clinical Trials Coordinator
Delivra Corp.
Hamilton, Ontario
05.2017 - 05.2020
- Managed preclinical and clinical projects in pain management, osteoarthritis, anxiety, Raynaud’s disease, varicose veins, and diabetic wound management.
- On-site clinical monitoring for two studies.
- Remote site monitoring and central data management for one study.
- Protocol development, ethics approval, and execution of a retrospective therapeutic cannabinoid study in peripheral nerve pain management.
- Executed a Phase IV single-site study and published the study results.
- Published three manuscripts, including one as the first author.
- Conducted market analysis and co-developed educational materials for several new Delivra products, supporting the enhancement of market positioning and product awareness.
Senior Clinical Research Coordinator II
Cliantha Research
Mississauga, Ontario
07.2016 - 05.2017
- Led coordination of Phase I/II study on allergen response in mild asthma patients
- Supported clinical operations with dose administration, vital signs, and structured interviews
- Managed study documentation, clinical operation, and clinic timelines for 10+ multiple-dose cohorts from recruitment through study closure.
- Supported study execution with dose administration, vital signs, and structured interview administration.
Clinical Research Coordinator II
INC Research Inc
Toronto, Ontario
03.2015 - 07.2016
- Simultaneously led the clinical execution of Phase I and II multiple ascending single and multiple dose studies in pain management and gastroenterology.
- Completed 15 or more cohorts.
- Supported clinical operations for abuse liability studies.
- Supported study execution with dose administration, vital signs, and structured interview administration.
Clinical Research Coordinator – Department of Anesthesia
Sunnybrook Health Science Centre
Toronto, Ontario
11.2013 - 03.2015
- Clinical, regulatory, and financial management of 5–7 clinical projects for the Department of Anesthesia at Sunnybrook Health Sciences and the Holland Orthopedic and Arthritic Centre.
- Managed the laboratory operating grants and academic awards for a research associate, post-doctoral fellow, and three graduate students in the basic science lab at the University of Toronto for a clinical investigator.
- Managed the Animal Use and Care Committee renewals for several In Vivo protocols.
- Coordinated the execution of a multi-site and a single-site clinical project.
- Supervised and managed two research assistants.
- Coordinated the 2014 Continuous Peripheral Nerve Blocks Preceptorship at the Holland Orthopedic and Arthritic Center.
- Obtained Health Canada approval for a Phase II clinical trial.
Quality Control Microbiology Analyst & Reviewer
Taro Pharmaceuticals
Brampton, Ontario
09.2007 - 11.2013
- Validated and implemented new testing methods, significantly reducing analyst errors, and improving laboratory performance.
- Reviewed data and revised control documents to mitigate errors, enhance data quality, and improve precision in analysis.
Quality Control Microbiology Analyst
CIBA Vision Sterile Manufacturing
Mississauga, Ontario
04.2007 - 09.2007
- Performed microbiology quality control testing of FDA- and Health Canada-regulated pharmaceutical products.
- Performed clean room qualification in a sterile GMP manufacturing facility.
- Provided aseptic and new personal training.
- Provided technical consultation for quality and production management.
Microbiology Laboratory Technician
Maxxam Analytics
Mississauga, Ontario
08.2006 - 04.2007
- Performed microbiology testing of food and environmental samples.
- Municipal adverse water testing and reporting.
Quality Control Laboratory Assistant I & II
NABI (Biotest) Biopharmaceuticals
Boca Raton, USA
02.2003 - 04.2006
- Performed microbiological testing and test method validation of sterile finished products, raw materials, and manufacturing equipment.
- Performed clean room validation of new production suites in a sterile GMP manufacturing facility.
- Environmental monitoring, microbiological and chemical water testing, aseptic training, and GMP gowning certification for new employees.
Education
Master of Science - Clinical Research Administration
Walden University
Minneapolis, Minnesota04-2013
Ontario Graduate Certificate - Pharmaceutical Regulatory Affairs & Quality Operations
Seneca College
Toronto, ON08-2010
Bachelor of Science - Molecular Biology/Microbiology/Biotechnology
Florida Atlantic University
Boca Raton, Florida12-2003
Associate of Arts - Medical Technology
Broward Community College
Davie, Florida06-2001
Skills
- Research Project Management
- GCP, GDP, GMP, GLP
- e-CRF design and validation
- User acceptance testing
- Data Management
- Data analysis
- Contract negotiations
- Budget management
- Change control
- Centralized Monitoring
- Quality Control
- Training
- Critical thinking
- On-site and remote clinical monitoring
- Quality Assurance
- Public speaking
- Team building and collaboration
- Strong leadership
- Excellent communication
- Risk Management
- Structured Interview Administration
- Phase I, II, III, and IV
- Non-intervention studies
Certification
- Clinical Research Professional Certification (CCRP), SoCRA, 11/01/14 - Present
- Phlebotomy, 05/01/19
Languages
- English, Fluent
- French, Basic
- Spanish, Basic
Volunteer Experience
- Canadian Cancer Society, Event Committee Member, Cambridge, Ontario, 2018
- Community Support Connections, Digital Literacy Guide, Cambridge, Ontario, 05/01/22, 02/28/23
Professionalmemberships
Society of Clinical Research Associates (SoCRA), 04/01/13 - Present
Technology Experience
- LIMS
- REDCap
- CTMS
- ETMF
- EISF
- Medidata Rave
- Fusion
- SharePoint
- One Drive
- Desire-to-Learn (D2L)
- Project R
- Microsoft: Word
- Excel
- PowerPoint
- Teams
- OneNote
- Outlook
- Zoom
- Cisco WebEx
- Google Meets
- Google Docs
- Dropbox
- Adobe Sign
- DocuSign
- Monday Board
- Survey Monkey
Affiliations
- 1st Degree black belt in Karate
- Amateur award-winning billiard player
- Avid social dancer trained in 4 distinct styles
References
References available upon request.
Timeline
Part-Time Martial Arts Instructor
Boundless Martial Arts
01.2025 - Current
Clinical Project Manager
Axiom Real-Time Metrics
10.2023 - 12.2024
Part-Time Professor
Conestoga College
09.2023 - Current
Senior Research Manager Pre-Clinical & Clinical Projects
Kapoose Creek Bio Corp.
08.2022 - 03.2023
Clinical Research Consultant
14517105 Canada Inc.
05.2020 - 08.2022
Part-Time Graduate Student Research Trainee
McMaster University
09.2019 - 09.2021
Clinical Trials Coordinator
Delivra Corp.
05.2017 - 05.2020
Senior Clinical Research Coordinator II
Cliantha Research
07.2016 - 05.2017
Clinical Research Coordinator II
INC Research Inc
03.2015 - 07.2016
Clinical Research Coordinator – Department of Anesthesia
Sunnybrook Health Science Centre
11.2013 - 03.2015
Quality Control Microbiology Analyst & Reviewer
Taro Pharmaceuticals
09.2007 - 11.2013
Quality Control Microbiology Analyst
CIBA Vision Sterile Manufacturing
04.2007 - 09.2007
Microbiology Laboratory Technician
Maxxam Analytics
08.2006 - 04.2007
Quality Control Laboratory Assistant I & II
NABI (Biotest) Biopharmaceuticals
02.2003 - 04.2006
Master of Science - Clinical Research Administration
Walden University
Ontario Graduate Certificate - Pharmaceutical Regulatory Affairs & Quality Operations
Seneca College
Bachelor of Science - Molecular Biology/Microbiology/Biotechnology
Florida Atlantic University
Associate of Arts - Medical Technology
Broward Community College
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