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 both national or international fields 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.
WORK CONDITIONS
- 35 hours weekly base;
- Pre-approved overtime paid;
- Flexible work schedule for work-family balance;
- Limited travel time;
- 4 weeks’ vacation after one year;
- 13 statutory holidays;
- Defined retirement benefits;
- Group insurance;
- 9.6 day off sick days;
RESPONSIBILITIES
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
REQUIREMENTS
- Master’s or Bachelor’s degree in an appropriate discipline and 6 years of experience in clinical research;
- Bilingualism;
- 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.
TO SUBMIT YOUR APPLICATION
- Final date to apply : December 31 2018
- By email : dotation@icm-mhi.org
- Your presentation letter and your resume must be combined in one file (Word or PDF) and it must be identified this way : Name_Last name (ex : Hamel_Danny)
- Please indicate the job title for which you’re submitting your application
We offer equal employment opportunities to all.
Only candidates that have been met will receive a written answer