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Clinical Trial Manager II, Dermatology, Rheumatology
Innovaderm Research Inc.Clinical Trial Manager overseeing site performance and monitoring deliverables for Indero, a dermatology-focused contract research organization. Leading CRA training, quality oversight, and clinical trial operations.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical research management, including oversight of clinical investigative sites and monitoring deliverables. Proficient in ICH/GCP standards, regulatory compliance, and effective leadership of clinical research associates.
Highest-signal resume keywords
Clinical Research ExperienceLead CRA ExperienceICH/GCP Standards KnowledgeMicrosoft Office Suite MasteryProblem-Solving Skills
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 MonitoringSite Performance AnalysisCorrective Action PlanningCRA Training DevelopmentSource Data VerificationQuality Control VisitsMetrics TrackingClinical Monitoring Plan DevelopmentCo-Monitoring VisitsBusiness Development Activities
Soft Skills
Leadership SkillsOrganizational SkillsTime ManagementRelationship BuildingJudgement
Industry Keywords
Clinical TrialsBiotechnologyPharmaceuticalCRODermatology
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Operationally manage and oversee clinical investigative sites and clinical monitoring deliverables for clinical trials
- Ensure clinical monitoring activities satisfy sponsors and comply with SOPs, regulations, good clinical practices, 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 a 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 visits with CRAs
- Coordinate and lead CRA meetings
- Perform co-monitoring visits with CRAs
- Participate in 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 acting in a Lead CRA or Clinical Team Leader role 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 multi-tasking skills
- Excellent judgement and problem-solving skills
- Occasional travel up to 10% of the time, including some travel outside of the country once possible
- Fluent in English, with excellent oral and written proficiency
- Experience in a CRO and in dermatology is an asset
- Must be legally authorized to work in the US
Benefits
Comp & perks- Flexible work schedule
- Home-based position
- Ongoing learning and development
- Attractive advancement opportunities