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Project Manager
Innovaderm Research Inc.. Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical research projects, ensuring compliance with GCP, ICH standards, and regulatory requirements while effectively coordinating teams and resources. Proven ability to communicate with stakeholders and manage project timelines and deliverables.
Highest-signal resume keywords
Clinical Trial ManagementGCP KnowledgeProject ManagementStakeholder CommunicationTeam Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchProject CoordinationRegulatory ComplianceData ManagementBudget ManagementRisk ManagementQuality AssuranceStudy DocumentationPatient RecruitmentOperational Planning
Soft Skills
Communication SkillsProblem-SolvingOrganizational SkillsTeam CollaborationTime Management
Tools & Technologies
Microsoft Office SuiteTMF ManagementStudy TrackersDatabase Management
Industry Keywords
PharmaceuticalBiotechnologyCROFDA RegulationsICH StandardsClinical PracticesSite ActivationInvestigator Meetings
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects
- Ensure compliance with study budgets, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements
- Serve as primary contact for sponsors, vendors and internal teams throughout studies
- Coordinate tasks and deadlines across departments
- Oversee project coordinators, SSU team members, RDA and RAC resources, prioritizing site activation activities
- Coordinate vendor supplies and services with site activation timelines
- Escalate risks to site activation timelines to Project Manager II
- Manage sponsor and stakeholder needs and expectations
- Ensure team members are trained on projects
- Plan project activities and required internal and external resources
- Manage quality of assigned work and deliverables
- Provide project status updates to stakeholders
- Reconcile study trackers and analyze discrepancies between planned and actual results
- Participate in corrective actions, change control and risk management
- Review and assist with drafting project operational plans, processes and manuals
- Ensure study documents and deliverables meet country requirements
- Oversee site feasibility, selection and qualification visit planning
- Monitor patient recruitment and site recruitment strategy plans
- Participate in Investigator’s Meeting planning and conduct
- Oversee central ethics and regulatory submissions with Regulatory Affairs
- Collect and maintain essential site documents throughout studies
- Assist with TMF quality reviews and audits for inspection readiness
- Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues
- Track site visits, project-specific training, monitoring reports, follow-up letters and site issue escalations
- Maintain project training matrices and confirm team training compliance
- Support sites with investigational products, study supplies, equipment and safety lab kits
- Work with Data Management to ensure CRF compliance, query resolution and data review through database lock
- Provide technical, therapeutic and project management expertise in training and process improvement
Requirements
What you’ll need- B.Sc. in a related field of study to clinical research
- At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry
- At least 2 years of experience coordinating activities related to clinical trial management
- 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
- Good problem-solving abilities
- Good organizational skills
- Strong ability to carry out different projects and work under pressure while meeting timelines
- Experience managing small to medium projects using a disciplined approach to project management
- Demonstrated ability to establish and deliver resource-based project plans
- Excellent people management skills; experience working with and managing teams in a matrix environment
- Must be legally authorized to work in the EU
Benefits
Comp & perks- Permanent full-time position
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
- Attractive advancement opportunities
- Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request