Clinical Research Project Manager

EDUCATION

UNIVERSITÉ DE MONTRÉAL- MONTREAL HEART INSTITUTE

Ph.D. Biomedical Sciences 2003 – 2007

M.sc. Biomedical Sciences 2000 – 2003

WORK EXPERIENCE

VERDUN HEALTHCARE CENTER 2009 – 2013

Clinical Project Manager

● Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.

● Participate in the development of study protocols.

● Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress report.

● Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

● Identify protocol problems, inform investigators, and assist in problem resolution efforts.

● Participate in preparation and management of research budgets and monetary disbursements.

● Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.

Clinical Study Coordinator (Multicenter Sponsored Study)

● Performed initiation, monitoring and close out visits.

● Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.

● Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

● Oversee subject enrollment to ensure that informed consent is properly obtained and documented.

● Updated CRFs and ethical submission related to clinical trials

● Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. ● Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

● Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

● Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

Chair of the institutional ethics research board

● Chaired this committee appointed by the Hospital Board of Directors with the mandate to approve, monitor, and review biomedical and behavioral research involving humans

● Conducted approximately 100 risk-benefit analysis to determine whether or not research should be done

● Ensured, both in advance and by periodic review, that appropriate steps be taken to protect the rights and welfare of humans participating as subjects in a research study

● Supervised IRB coordinator and administrative assistant

Academic Researcher

● Served as principal investigator in research project on fall prevention in hemodialysis patients

● Completed redaction of research project protocols, Consent forms, scientific manuscripts

● Completed manuscript submission to peer-to-peer scientific journals

● Made submissions for government subsidy for research projects and funding.

MONTREAL HEART INSTITUTE 2001 – 2005

Clinical Study Coordinator

● Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.

● Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

● Oversee subject enrollment to ensure that informed consent is properly obtained and documented.

● Updated CRFs and ethical submission related to clinical trials

● Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. ● Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

● Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

● Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

Co-investigator of clinical research trials

INESSS (Quebec National Institute for Health Excellence) 2016 – today

Scientific Advisor - Pharmacotherapy

Perform Study Design Quality/methodology Assessment.

Perform Study Rational, and study results assessment and evaluation.

Perform pharmacotherapy scientific literature review.

Identify and chose valid comparable treatment.

Interpret and analyze all pertinent scientific data.

Write advices to Minister of Health and conduct correspondence with sponsors.

Performed recommendations to the scientific committee for drugs reimbursement in Quebec.

Interpreted and analyzed all pertinent scientific data.

Communicated effectively all clinical and economical aspects to all pertinent individuals involved.

GENZYME a Sanofi Company 2013 – 2015

Regional Medical Advisor - Multiple Sclerosis

Participated in site selection, start-up/regulatory, initiation, monitoring and close out visits

Assisted and developed investigator-sponsored study/research protocols

Participate/present study rational and attend Investigator Meetings.

Leveraging clinical/therapeutic expertise by working in close relation with clinical operations, government affairs marketing and sales teams.

Identify best potential investigators and best potential sites to recruit for clinical studies.

Work with CRA during the Initiation visits.

Built peer to peer relationships with neurologists, cultivating and developing effective internal and external relationships by positively influencing others to support the achievement of strategic goals and initiatives.

AMGEN INC. 2006 – 2009

Medical Science Liaison- Nephrology & Heart failure

Participated in site selection, start-up/regulatory, initiation, monitoring and close out visits

Assisted and developed investigator-sponsored study/research protocols

Won a Gold Bravo Award in 2008 as a Role Model for demonstrating the attributes of Team Spirit and Teamwork with Clinical Operations Team, Sales & Marketing, CHE managers and Medical Affairs partners

Worked in partnership with the Clinical Operation and Government Affairs Manager to present new results on company products to Health Canada in the form of scientific presentations on efficacy and safety for the use of a product in specific defined circumstances

Led the Research Chair team, developing and enhancing good relations and peer-to-peer scientific credibility with researchers partnering with the company on different research projects

BAYER HEALTHCARE 2005 – 2006

Scientific Development Liaison- Hypertension

Participate/present study rational and attend Investigator Meetings.

Worked with key opinion leaders at the Advisory Board to better understand how the clinical research projects might help their clinical practice in hypertension

Drove strategy and maximized the impact of local clinical research programs to support objectives of possible commercial expansion of marketed products, in conjunction with Marketing

Developed peer-to-peer relations with the key opinion leaders in the therapeutic area based on scientific knowledge and credibility

Martine Blanchet, Ph.D. 29/09/2017 4

MEMBERSHIP Current

Association of Clinical Research Professionals (ACRP)

Clinical Research Association of Canada (CRAC)

VOLUNTEERING Current

Member- Preimplantation Genetic Diagnosis Ethics Working Group

McGill Fertility Clinic, Montreal

McGill University

PUBLICATIONS

Available on demand

Contact this candidate