CATALIS is hiring!

TITLE: Project Manager – Clinical Trials
LOCATION: Montreal, QC
INDUSTRY: NPO, Clinical trials
Permanent position, full time

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.

• 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.

– 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.

– 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).

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