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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. Proficient in project planning, execution, and monitoring, with strong communication and organizational skills to meet project timelines and stakeholder expectations.
Highest-signal resume keywords
Clinical Trial ManagementGood Clinical Practice (GCP)Project ManagementRegulatory ComplianceTeam 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 PlanningData ReviewBudget ManagementRisk ManagementSite ActivationMonitoring ReportsFeasibility AssessmentResource-Based Project PlansStudy Document Management
Soft Skills
Communication SkillsProblem-Solving AbilitiesOrganizational SkillsTeam CollaborationRelationship Building
Tools & Technologies
Microsoft Office SuiteClinical Trial Management SystemsTracking ToolsTraining MatricesStudy Trackers
Industry Keywords
Pharmaceutical IndustryBiotechnologyContract Research Organization (CRO)FDA RegulationsICH Standards
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 requirements, and study-specific requirements
- Serve as a 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 for site activation activities
- Coordinate vendor supplies and services with site activation timelines
- Escalate at-risk site activation timelines to Project Manager II
- Manage sponsor and stakeholder needs and expectations
- Support team training and project resource planning
- Manage work quality and deliverables; provide project status updates
- Reconcile study trackers and analyze planned-versus-actual discrepancies
- Support corrective actions, change control, and risk management
- Review and assist with drafting project operational plans, processes, and manuals
- Ensure study documents and deliverables meet applicable country requirements
- Oversee site selection, feasibility questionnaires, and site qualification visit planning
- Monitor patient recruitment and subject status; follow up with sites on recruitment strategies
- Participate in Investigator’s Meetings
- Oversee central ethics and regulatory submissions with Regulatory Affairs
- Ensure collection and maintenance of essential site documents
- Support 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, monitoring-plan compliance, and site issue escalations
- Maintain the project-specific training matrix and confirm team training completion
- Ensure sites have necessary study materials and equipment
- Support CRF compliance, query resolution, data review, and database-lock timelines with Data Management
- Provide technical, therapeutic, and project management expertise for 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 experience coordinating activities related 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
- Applicants must be legally able to work in the United States
Benefits
Comp & perks- Stimulating work environment
- Attractive advancement opportunities
- Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request