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The Montreal Health Innovations Coordinating Center (MHICC) is a full service academic research organization targeted on multicenter and multinational clinical trials with large pharmaceutical and biotechnological firms. We provide services to the academic community and to the pharmaceutical, biotechnology and medical device industries, in the fields of cardiology, neurology, oncology, dermatology, endocrinology and pharmacogenomics. Our employees work in a stimulating and dynamic environment in order to offer our clients a full range of services from the development and initiation of a clinical study to the production of the final clinical study report. Our main goal is to establish a partnership, with our customers, in order to ensure a successful implementation of their project while respecting the budget, timelines and always ensuring the highest standards of quality.
Under the supervision of the Director, the Senior Project Manager will assume the following responsibilities:
Act as an advisor/mentor to junior Project Managers
Assist in the analyses and resolution of the study specific issues
Review the protocol, Case Report Form (CRF), Investigator Brochure and all study related documents
Ensure the scope of work is respected by the study team
Generate the study management plan, monitoring plan, recruitment plan and communication plan in collaboration with MHICC management and sponsor
Organize study start up activities, including investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions and participation in Investigator meeting planning and execution
Collect and retain all study essential documents in compliance with GCP/ICH on clinical trial documentation and record retention guidelines
Develop study-specific tools as well as project management tools in order to assure consistency and quality data
Provide training to internal and external study personnel on protocol, CRF completion, adverse event reporting, central laboratory functioning and all study requirements before the beginning of the study and on an ongoing basis
Create and present a monthly progress report, including achievements and potential challenges and/or risks for MHICC upper management
Ensure that study drug, Central laboratories supplies and all other essential study supplies are shipped to sites prior to the site initiation visit
Assure correspondence and information management between sponsor, sites, CRAs, subcontractors, suppliers, vendors and MHICC is adequate and timely
Review and approve clinical monitoring reports
Ensure review of the clinical trial master file for completeness
Provide work instructions/guidelines to their assigned Clinical Trial Assistant and CRAs
Proactively identify and resolve issues that could jeopardize the timely completion of the clinical trial
Assist sites in preparation of sponsor, regulatory agencies or MHICC audits
Participate in MHICC and/or sponsor required training programs
Facilitate and assist payments to investigator/site and study related invoices
Ensure that sponsor requirements, timelines and deliverables are met
Master’s or Bachelor’s degree in an appropriate discipline and 6 years of experience in clinical research;
4 years relevant experience in the pharmaceutical industry, biotechnology, or in a contractual research organization;
Knowledge of Microsoft Office including Excel;
Selected candidates must demonstrate excellent organization, communication and management skills and exceptional leadership skills.
We invite you to submit your CV by January 30, 2016 to: email@example.com.
www.icm-mhi.org and www.mhicc.org
We are an equal opportunity employer
Only interviewed candidates will receive a response.
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