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Senior Clinical Trial Manager, Dermatology, Rheumatology
Innovaderm Research Inc.. Manage and oversee clinical investigative sites and clinical monitoring deliverables for clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing clinical trials, ensuring compliance with ICH/GCP standards, and mentoring clinical research associates. Proficient in developing monitoring tools and conducting training while maintaining strong relationships with stakeholders.
Highest-signal resume keywords
Clinical Research ExperienceLead CRA ExperienceICH/GCP KnowledgeMicrosoft Office MasteryRegulatory Compliance
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 Trial ManagementMonitoring DeliverablesQuality ControlSource Data VerificationCorrective Action PlansClinical Monitoring Plan DevelopmentAnnotated Site Visit ReportsMetrics TrackingProject-Specific TrainingSite Performance Analysis
Soft Skills
LeadershipOrganizational SkillsTime ManagementProblem-SolvingRelationship Building
Industry Keywords
BiotechnologyPharmaceuticalCROClinical Investigative SitesSponsor ExpectationsRegulatory RequirementsCRA MeetingsClient MeetingsProposal DefenseDermatology Experience
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage and oversee clinical investigative sites and clinical monitoring deliverables for clinical trials
- Ensure monitoring activities meet sponsor expectations, timelines, SOPs, regulations, GCP, and study-specific requirements
- Identify quality issues and trends related to site performance and monitoring activities
- Summarize findings and establish corrective action plans
- Serve as point of contact for CRAs and Lead CRAs on assigned projects
- Mentor and oversee CRAs and Lead CRAs
- Review site visit reports and track metrics for compliance
- Contribute to Clinical Monitoring Plan development
- Prepare and conduct project-specific CRA training
- Develop annotated site visit reports and monitoring tools, including source data verification worksheets
- Conduct quality control and co-monitoring visits with CRAs
- Coordinate and lead CRA meetings
- Support business development activities, including client meetings, proposal defense meetings, RFPs, and RFIs
Requirements
What you’ll need- B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
- At least 8 years of clinical research experience, including prior monitoring experience
- At least 2 years of experience as a Lead CRA or Clinical Team Leader in the biotechnology, pharmaceutical, and/or CRO industry
- Strong knowledge of ICH/GCP standards and applicable regulatory requirements
- Excellent mastery of Microsoft Office suite (Word, Excel, PowerPoint)
- Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites, and sponsors
- Excellent leadership, organizational, time management, and multitasking skills
- Excellent judgment and problem-solving skills
- Occasional travel up to 10% of the time, including some travel outside Canada when possible
- Fluent in English, with excellent oral and written skills
- CRO and dermatology experience is an asset
- Must be legally authorized to work in Canada
Benefits
Comp & perks- Flexible work schedule
- Home-based position
- RRSP
- Ongoing learning and development
- Medical, dental, and vision insurance
- Vacation days
- Personal days
- Virtual medical clinic
- Public transit discounts
- Social activities
- Hybrid work option
- Advancement opportunities
- Permanent full-time position