Project Manager II / Gestionnaire de projet II (Canada)

Indero; Montreal (administrative region); Remote; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Permanent full-time

Comprehensive benefits

Ongoing learning

Job summary

Indero, a Montreal-based CRO, seeks a Project Manager II to lead multisite clinical trials from initiation through closure, coordinating resources and timelines to meet scope and budget in line with GCP/ICH standards.

You will act as the main sponsor liaison, oversee study deliverables, start-up activities, vendor coordination, and risk management, with opportunities for professional growth in a collaborative environment. Remote work is possible across Canada.

Qualifications

• Minimum 5 years industry experience with ≥3 years in Phase I–III project management.
• Experience managing dermatology and/or rheumatology trials.

Responsibilities

• Serve as primary sponsor contact and provide trial progress updates.
• Oversee study deliverables: plans, protocol, ICF, eCRF, TLFs, and reports.
• Plan Investigator’s Meetings and site initiation activities.
• Ensure site readiness with materials and equipment.
• Lead start-up activities including TMF setup and site contracting.
• Coordinate with Regulatory Affairs, Data Management, and other functions.
• Maintain audit readiness and oversee QA and risk management.
• Control budget, timelines, resources, and vendor management.
• Mentor core project team and collaborate with sites and internal teams.

Skills

Project management

Budget management

Stakeholder communication

Regulatory compliance

GCP/ICH knowledge

Education

B.Sc. in a related field of study to clinical research

Tools

Microsoft Office

Job description

The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline)

This role will be perfect for you if:

• You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects
• You are looking to position yourself in an environment where you can grow your career alongside the company

IMPACT AND RESPONSIBILITIES

Client interactions

• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress

Project planning

• Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.
• Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.
• Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.

Quality and risk management

• Ensure assigned studies are “audit ready” at all times.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality assurance audits.

Project budget and timelines

• Control the project budget, with particular attention to internal hours allocated to all activities.
• Identify out of scope activities for change orders.
• Proactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
• Communicate effectively with study team members, functional departments, and senior management.
• Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.

Project team leadership

• Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
• Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.

Brand name: Indero

The Work Environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive opportunities for advancement.

In this position, you will be eligible for the following perks:

• Permanent full-time position
• Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development opportunities

Work Location

The successful candidate for this position has the option to work remotely anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives).

Occasional visits to our Montreal office may be required or encouraged.

About Indero

Indero is a CRO specialized in clinical trials. Based in Montreal, we have built a strong reputation for the quality of our research and services that exceed client expectations. Indero continues to grow and expand across North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. Accommodations are available throughout the recruitment and selection process for applicants with disabilities, upon request.

Please note that Indero only accepts applicants who are legally authorized to work in Canada.

Education

• B.Sc. in a related field of study to clinical research

Experience

• At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management
• Experience managing dermatology and/or rheumatology trials
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.
• Experience managing dermatology trials an asset

Knowledge and skills

• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
• Excellent knowledge of Microsoft Office suite
• Excellent oral and written skills in English, French is an asset
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Good organizational skills
• Strong ability to carry out different projects and work under pressure while meeting timelines