Project Manager – Early Phase and Translational Research

Innovaderm Research Inc.

. Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned early-phase clinical research projects .

Posted 9/15/2026full-timeMontreal • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing early-phase clinical research projects, ensuring compliance with GCP, ICH standards, and regulatory requirements while effectively coordinating cross-functional teams and stakeholder communications.

Highest-signal resume keywords

Clinical Trial ManagementGCP KnowledgeProject ManagementStakeholder ManagementRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchProject PlanningRisk ManagementData AnalysisSite ActivationMonitoring ToolsStudy Tracker DevelopmentDocumentation ReviewRegulatory SubmissionsCRA Training

Soft Skills

Communication SkillsProblem-Solving AbilitiesTeam CollaborationCreativityAdaptability

Tools & Technologies

Microsoft Office SuiteSmartsheet

Industry Keywords

Pharmaceutical IndustryBiotechnologyCROFDA RegulationsCanadian RegulationsICH Guidelines

About the role

Key responsibilities & impact

Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned early-phase clinical research projects
Manage and oversee clinical investigative sites and clinical monitoring deliverables
Serve as a primary contact for sponsors, sites, CRAs, vendors and internal teams
Coordinate tasks and deadlines across project departments
Oversee site activation resources and coordinate vendor supplies and services
Escalate risks to site activation timelines
Manage stakeholder needs and expectations
Plan project activities and resources
Manage quality of assigned work and deliverables
Provide project status updates
Ensure tasks comply with budgets, scope, timelines, SOPs, GCP, regulatory and study-specific requirements
Reconcile study trackers and analyze planned-versus-actual discrepancies
Participate in corrective actions, change control and risk management
Review and assist with project operational plans, processes and manuals
Ensure study documents and deliverables meet country requirements
Oversee site selection, feasibility questionnaires and site qualification visits
Monitor patient recruitment and subject status
Participate in Investigator Meetings
Oversee central ethics and regulatory submissions with Regulatory Affairs
Collect and maintain essential site documentation
Assist with TMF quality reviews and audits
Support clinical monitoring activities, CRA training, monitoring tools, visit report reviews and site issue identification
Track site visits, training, monitoring reports, follow-up letters and site-related escalations
Maintain the project training matrix
Ensure sites have required investigational products, supplies, equipment and laboratory kits
Support CRF compliance, query resolution and data review through database lock
Develop study trackers and site/Sponsor dashboards in Smartsheet
Provide technical, therapeutic and project management expertise for training and process improvement
After documented training, perform limited clinical monitoring visits according to monitoring plans, SOPs, ICH/GCP guidelines and applicable regulations

Requirements

What you’ll need

B.Sc. in a related field of study to clinical research
Minimum 3 years of relevant industry experience in the pharmaceutical, biotechnology or CRO industry
At least 2 years of experience coordinating activities related to clinical trial management
Experience in early phase is considered a strong asset
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
Excellent communication skills
Ability to work in a team environment and establish good relationships with colleagues and sponsors
Strong sense of creativity and process improvement
Excellent judgement and problem-solving abilities
Ability to carry out different projects and work under pressure while meeting timelines
Detail-oriented with excellent documentation skills
Quick learner with good adaptability and versatility
Must be legally able to work in Canada

Benefits

Comp & perks

Flexible work schedule
Permanent full-time position
Complete benefits: medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities
Ongoing learning and development
Option to work from home anywhere in Canada or from the Montreal headquarters
Attractive advancement opportunities