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MSc Silvia Shardonofsky
Medical Director at Milestone Pharmaceuticals, Inc.
Professional Background
Dr. Silvia Shardonofsky is a highly accomplished Medical Doctor with extensive experience in clinical research, serving as a Project Manager and contributing significantly to multi-national studies across various phases (II to IV). Her distinguished career spans over a decade during which she has demonstrated exceptional leadership and expertise in managing complex clinical trials. Currently, Dr. Shardonofsky is the Medical Director at Milestone Pharmaceuticals, Inc., a role that highlights her capability to drive forward innovative medical solutions in the industry.
Prior to her current position, Dr. Shardonofsky held pivotal roles with prominent organizations, including Syntactx and Vantage BioTrials Inc., where she orchestrated project management efforts aimed at ensuring the success of clinical research operations. In her capacity as a Senior Project Manager and Medical Reviewer at the Montreal Health Innovations Coordinating Center (MHICC) and the Montreal Heart Institute, she played a vital role in overseeing clinical trials, ensuring adherence to regulatory standards, and contributing to the advancement of medical knowledge in cardiology.
With a rich portfolio that includes experience at the World Health Organization (WHO), Université du Québec à Montréal (UQAM), and the Department of Family Medicine at McGill University, Dr. Shardonofsky's career is marked by her significant contributions to the health sector. She has been instrumental in leading research initiatives, and her commitment to improving patient outcomes is evident through her roles as a Scientific Advisor at Environnement Canada and as a Cardiologist at Dr. Cosme Argerich Hospital.
Education and Achievements
Dr. Silvia Shardonofsky’s educational background is as impressive as her professional one. She holds a Doctor of Medicine (M.D.) in Cardiology from the University of Buenos Aires, which laid a strong foundation for her medical expertise. She further enriched her knowledge with a Master’s Degree (M.Sc.) in Toxicology and Environmental Health from the Université de Montréal, followed by a Doctor of Philosophy (Ph.D.) in Health/Health Care Administration/Management, also from the Université de Montréal. These degrees not only showcase her profound understanding of health care systems but also her commitment to research and education in the medical field.
Additionally, she is certified as a Clinical Research Professional (CCRP) by the Society of Clinical Research Professionals (SOCRA), highlighting her proficiency in conducting clinical research with an emphasis on ethical standards and regulatory compliance.
Her achievements extend into numerous trials and studies related to Cardiology, Oncology, Infectious Diseases, and Respiratory Medicine. Dr. Shardonofsky has demonstrated her skill in the domain of pharmacy-vigilance, drug safety, and post-marketing surveillance, reinforcing her reputation as a leader in clinical research.
Key Expertise
Dr. Shardonofsky is proficient in several critical areas essential to successful clinical research. Her expertise encompasses:
- Clinical Research Management: A strong background in managing complex, multi-site clinical trials, ensuring that projects adhere to timelines and budgetary constraints while complying with ICH, EMA, and GCP guidelines.
- Data Safety Monitoring: Serving as a Medical Reviewer and Manager of Data Safety Monitoring Committees, her role ensures that patient safety is prioritized throughout the research process.
- Ethics in Research: Deeply knowledgeable in research ethics and regulatory requirements, she upholds the highest ethical standards in all her project dealings.
- Therapeutic Areas: Extensive experience in clinical research spanning multiple therapeutic areas like Cardiology, Oncology, and Infectious Diseases. This highlights her versatility and ability to adapt to various medical specialities.
- Collaboration and Communication: Proven ability to collaborate effectively with cross-functional teams, including clinical investigators, regulatory bodies, and healthcare professionals, fostering an environment of transparency and trust.
Throughout her career, Dr. Shardonofsky has been recognized for her invaluable contributions to clinical research and the healthcare community. Her balanced focus between theoretical research and practical application not only enhances her presentations at conferences but also enriches her team’s capacity to innovate and lead in the ever-evolving field of medicine.
Conclusion
Dr. Silvia Shardonofsky’s impressive academic credentials and her commitment to clinical excellence make her a distinguished figure in the field of clinical research. Her career trajectory showcases her ability to thrive in various roles, leading multi-disciplinary teams towards achieving significant advancements in healthcare. As she continues to push the boundaries of what is possible in clinical research, her contributions will undoubtedly shape the future landscape of medical research.
In summary, with her 10+ years of experience, Dr. Shardonofsky embodies professionalism, expertise, and an unwavering dedication to improving patient care through rigorous clinical research. Her journey from being a Cardiologist to a key player in medical research administration demonstrates a commitment not just to her profession, but to the broader health community. Dr. Shardonofsky remains an invaluable asset to any organization, driving forward innovative health solutions.
tags=[
Clinical Research
Project Management
Cardiology
Oncology
Clinical Trials
Drug Safety
Pharmacy-Vigilance
Research Ethics
Healthcare Administration
Environmental Health
International Studies
Health Care Management
Data Safety Monitoring
Clinical End-Point Adjudication
Public Health
Medical Reviewer
Pharmaceutical Industry
Toxicology
Multi-national Studies