CATALIS is hiring!
TITLE: Project Manager – Clinical Trials
LOCATION: Montreal, QC
INDUSTRY: NPO, Clinical trials
Permanent position, full time
SUMMARY OF THE POSITION
Under the authority of the Director General, the Project Manager collaborates in activities related to the accelerated evaluation service for clinical trials in Quebec; and other operational activities of CATALIS.
MAIN RESPONSIBILITIES
• Assists the Managing Director in the implementation of the accelerated evaluation service for clinical trials
– Collaborate in the definition and continuous improvement of the modus operandi of the new service;
– Collaborate in the implementation of preliminary works with public and private users;
– Coordinate the IT developments required (Nagano) to maximize efficiency and service performance monitoring with participating establishments.
• Actively participates in the accelerated evaluation service for clinical trials
– Facilitates the operational feasibility process, including the management of the confidentiality agreement;
– Ensures that all documents related to the promoter’s research project are complete and comply with documents pre-approved by the department;
– Uses a CTMS system to create the budget framework for research projects, compares the promoter’s budget with the reference price list, then neutrally coordinates the negotiation activities between the researcher / establishment and the promoter;
– Checks the conformity of the contract (mCTA) of the research project versus the pre-approved model, and coordinates the signature process with the Parties;
– Checks the conformity of the consent form of the Research Project versus the pre-approved model, and adapts the multi-center FICs by adding the administrative information of the participating establishments;
– Prepares the filing of research projects in the Nagano computer system of the evaluating CER;
– Follow up with the local project manager of the establishments with regard to the institutional suitability assessments;
– Coordinate the amendments that impact the FIC and / or the contract (legal / budget) of the Research Projects which were initially revised in an accelerated manner;
– Maintains a dashboard, ensures that projects are activated within target deadlines, analyzes deadlines (if applicable) and identifies / coordinates the implementation of solutions to maximize performance;
– Follow up with users to ensure their satisfaction with the service.
• Assists the general manager in the various operational activities of the organization
– Chair and / or assist on the various operational sites of the network, write minutes and follow up on actions with the Network;
– Coordinate the development, implementation and continuous improvement of common tools and standards developed by the Network;
– Responsible for collecting and monitoring aggregated performance indicators and monitoring Canadian and international performance;
• Performs all other tasks related to this position.
REQUIREMENTS
– Bachelor’s degree (BAC) or university degree in science (or experience deemed equivalent);
– More than 5 years of experience in the management of clinical research in a health establishment in Quebec;
– Complementary experience in a pharmaceutical company or in a contractual research organization (CRO) is an asset;
– Knowledge of the Nagano computer system is an important asset;
– Certified Clinical Research Professionals (CCRP®s) certification is an asset;
– Project Manager Professional (PMP) certification is an asset.
SKILLS AND QUALIFICATIONS
– Unifying leadership and great ability to mobilize;
– Highly motivated and performance oriented;
– Ability to work in a fast-paced environment and build good relationships with colleagues, sites and promoters;
– Excellent judgment and problem solving skills;
– Experience in project management and operations management;
– Strong knowledge of ICH / GCP standards and applicable provincial regulatory requirements
– Initiative and autonomy;
– Excellent communication skills, both in French and in English (spoken and written);
– Great listening skills;
– Writing skills;
– Political sense, diplomacy and integrity;
– Very good knowledge of Microsoft Office suite software (Word, Excel, Outlook and PowerPoint).
