MI
Gestionnaire optimisant les espaces, processus et sécurité physique de Mila, pôle montréalais de recherche en IA. Coordination stratégique avec chercheurs, administration, TI et parties prenantes.
II
Project Manager – Early Phase and Translational Research
Posted 3 weeks ago
About the role
- Project Manager overseeing early-phase clinical research, site operations, and monitoring deliverables at Innovaderm, a dermatology-focused CRO. Coordinating sponsors, sites, vendors, and clinical teams.
Responsibilities
- 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
- 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
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Project Manager leading full - lifecycle business, communications, and digital initiatives for Canadian IT consultancy Symbiotic Digital. Coordinating stakeholders, vendors, governance, risks, and Agile delivery.
Project Manager leading strategic business enablement and transformation initiatives for an IT services company. Managing governance, stakeholders, Agile delivery, risks, and project lifecycle execution.
Senior Project Manager leading building restoration, envelope investigations, and property assessment projects at multidisciplinary consulting firm TCG. Providing technical leadership, client guidance, and team mentorship.
Responsable de projets routiers MTMD chez Norda Stelo, firme d’ingénierie et d’infrastructures. Gestion d’équipes, travaux, budgets et livrables pour des projets majeurs au Québec.
Senior Project Manager leading complex industrial software projects for AVEVA, a global industrial software company. Driving multi - site delivery from initiation through go - live and handoff.
Executive Director leading dementia clinical research project management at Worldwide Clinical Trials, a global CRO. Overseeing complex studies, teams, sponsors, budgets, and business development across North America and Europe.
Senior Project Manager leading $100M - $1B+ institutional and defence construction projects for Ledcor Building. Overseeing pursuits, procurement, delivery, and government stakeholder relationships across Ontario.
Project Manager leading Group Benefits operations transformation at Manulife, an international financial services provider. Improving service, governance, automation, risk management, and member outcomes.
EPMO Project Manager translating research initiatives into actionable plans at ESO, a data and software company improving community health and safety. Managing RPI projects and outcomes.