Project Manager, Clinical Trials

**TITLE**: Project Manager
**INDUSTRY**: Clinical Trials
**LOCATION**: Montreal, QC (Hybrid working model)
Permanent, full time position

JOB SUMMARY
Under the authority of the President and CEO, the Project Manager collaborates in the implementation and conduct of activities related to the FAST TRACK evaluation service for clinical trials in Québec.

ABOUT OUR CLIENT
Our client is a non-profit organization mandated by the Québec Government to increase the number of clinical trials conducted by companies in Québec, facilitate collaboration between the various players in the life sciences sector and accelerate the development of innovative treatments.

Their mission is to optimize the clinical research environment in Québec to maximize private investment and accelerate the development of innovative patient care; and their vision is to create an environment that allows all patients to easily access clinical trials in Québec.

Our client is supported by a large network of partners, including public healthcare institutions, pharmaceutical companies, contract research organizations, and patient organizations.

KEY RESPONSIBILITIES
- Actively participates in the implementation and conduct of the FAST TRACK evaluation service for clinical trials
- Attends the pre-qualification activities for sponsors who will use the FAST TRACK evaluation service;
- Facilitates the sponsor's operational feasibility process, including the management of the confidentiality agreement;
- Ensures that all documents related to the sponsor’s Research Project are complete and compliant with the FAST TRACK Assessment Service documents;
- Verifies that the Research Project’s contract is in compliance with the approved master template, and coordinates signature processes with all parties concerned;
- Verifies that the Research Project’s informed consent form (ICF) is in compliance with the master template and adapts the multicentre ICF by adding administrative information from participating institutions;
- Assists the site researcher with the Research Project budget analysis (when requested);
- Prepares, in collaboration with the local research team, the submission of the Research Project in the Nagano platform of the reviewing and participating (MEO) sites;
- Coordinates and animates weekly meetings with the sponsor’s Research Project clinical trial manager and follows up on actions with parties concerned;
- Prepares the Research Project amendments for submissions to the Nagano platform of the reviewing REB and monitors ensuing evaluation activities;
- Maintains an activities dashboard, ensures Research Project activation within targeted milestone deadlines, analyzes deadlines achieved (if applicable) and identifies/coordinates the implementation of solutions to maximize performance;
- Follows up with service users to obtain their feedback and ensures their satisfaction with the service;
- Assists upper management with the preparation of workshops with the public and private members of the network. These workshops aim to identify simple and effective solutions to optimize the clinical research environment in Quebec;
- Performs all other duties related to this position.

**REQUIREMENTS**:

- Bachelor's degree (B.A or B.Sc) (or experience deemed equivalent);
- A minimum of 5 years’ experience in clinical research management in a pharmaceutical company, in a contract research organization (CRO) and/or in a healthcare institution in Quebec;
- A minimum of one (1) year experience in management or conduct of clinical research in a healthcare institution in Québec - mandatory;
- Knowledge of the Nagano platform is an important asset;
- Expertise in the administrative management of a research ethics board in a network healthcare institution is an asset.

SKILLS AND QUALIFICATIONS
- Unifying leadership and ability to mobilize;
- Highly motivated and performance-oriented;
- Ability to work in a rapidly changing environment and build good relationships with colleagues, sites, and sponsors;
- Excellent judgment and problem-solving skills;
- Experience in project and operations management;
- Strong knowledge of ICH/GCP standards and provincial regulation requirements;
- Initiative and autonomy;
- Excellent communication skills, in both French and English (spoken and written);
- Great listening skills;
- Editorial skills;
- Political acumen, diplomacy, and integrity;
- Very good knowledge of Microsoft Office suite software (Word, Excel, Outlook and PowerPoint).

WORKING CONDITIONS
- Full-time position
- Flexible schedule at 35h/week
- Location: Montreal and telework
- Competitive Insurance Program