Core Qualifications
- Medical Degree and medical practice experience
- Pharmaceuticals Expert
- Deliver high quality medical information
- Evaluate clinical study protocols
Experience
Consultant in Medical Affairs/Medical Science Liaison
2019 – 2022
Private Company – Canada
- Develop enduring value-based trusted partnerships, through scientific engagement and exchange, with healthcare professionals and institutions
- To generate actionable and valuable insights and propose solutions.
- Communicate in an accurate, fair and balanced manner, the benefits, risks, appropriate use and clinical value of the products and solutions.
- A good understanding of clinical development and clinical research. Critically evaluate clinical study protocols, reports and publications
- Engagement with key opinion leaders, key institutions, clinical investigators
- Engage in scientific exchange to communicate medical evidence and gather medical insights.
- Provide scientific expertise, and engage in ongoing scientific exchange and balanced discussion of science.
- Provides high quality scientific and medical Information to both internal and external stakeholder’s on request and in a timely manner.
- Maintains an up to date and high level knowledge of the therapy area, including company products, new and emerging research areas, therapeutic issues and trends
- Product launch preparation and execution.
Clinical Research Associate
2017 – 2019
Covance – USA
- Monitored Oncology Trials
- Conducting site monitoring visits (MV) at assigned clinical sites for Oncology studies
- Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects
- Evaluate the quality and integrity of the reported data, site efficacy, drug accountability
- Performing data verification of source documents, Ensuring completion, collection of SAEs
- Monitor completeness and quality of Regulatory Documentation
- Maintenance of clinical documents, protocol, amendments, summary of changes, ICFs. CSRs. SAE narratives and patient summaries
- In-patient and Out-patient care
- Site selection and initiation visits,
- Organize and manage trial master file (TMF),
Generating correspondence and reports without secretarial help,
- Verify that documentation of collected data is complete and accurate,
- Electronic Data Capture (EDC) system; Review Data/Listing/Auto and Manual Queries,
Report adverse events as required by regulatory and sponsor SOP guidelines,
- Investigator site progress monitoring, Database Lock.
- Worked both as a Site Monitor and an In-house CRA
- Investigator site progress monitoring for cardiovascular imaging studies Phase I and II
- Review Data/Listing/Manual Queries,
- Monitor study site’s compliance with GCP guidelines,
- Perform periodic visits to monitor compliance with recruitment, informed consent and study procedure guidelines, Work on TMF reconciliation,
- Resolves site regulatory issues, questions and concerns discovered during visits
- Reviews site-level data in clinical systems, evaluates data quality issues, and implements follow-up response
- Act as an in-house CRA: Provide support to the clinical operations team to assist with the execution, management and maintenance of clinical studies
- Coordinate preparation, collection, review and tracking of key clinical study documents, essential documents as needed
- Support set-up and maintenance of TMF
- Preparation of FDA audits.
Family Medicine Physician
2010 – 2015
Kangneier Children Hospital – China
- Diseases Diagnosis and treatment
Clinical Research Associate
2008 – 2009
INC Research – Canada
- Full independent home-based monitor for a large Phase III Vaccine study (three sites, visited once a week),
Clinical Research Associate
2007 – 2007
Bristol-Myers-Squibb, USA
- Monitored Clinical Trials of Cardiovascular Disease and Rare Disease
Research Associate
1999 – 2002
National Research Council – Canada
- Research Subject: Role of certain knock-out genes in neuronal death following stroke
- In-patient and Out-patient care
Resident Physician
October 1996 – December 1998
Beijing SOS International Clinic – China
- Diseases Diagnosis and treatment
Research Assistant
September 1993 – September 1995
University of Ottawa – Canada
- Conduct Neuroscience Research in the Department of Pharmacology
