Clinical Trial Manager II, Dermatology – Rheumatology

This is a fully remote position, open to applicants in Europe.

📋 Description

• Manage and oversee clinical investigative sites along with clinical operations deliverables for clinical trials.

• Train and supervise CRA activities while managing CRA transitions.

• Identify and address performance and quality monitoring issues at sites.

• Ensure compliance with study plans, timelines, budgets, SOPs, ICH/GCP guidelines, regulations, laws, and specific study requirements.

• Analyze KPIs, project meetings, site communications, and audit findings to recognize trends and develop corrective action plans.

• Act as the primary point of contact for clinical operations matters and deliverables for sponsors and project teams.

• Participate in internal, sponsor, and investigator meetings.

• Oversee risk assessments and implement mitigation strategies.

• Maintain site contact lists, coordinate site training, and supervise site screening and enrollment processes.

• Monitor site visit report metrics and evaluate protocol deviations and related action items.

• Create monitoring plans and contribute to study plans, manuals, reference materials, logs, and site worksheets/instructions.

• Prepare and deliver project-specific CRA training.

• Conduct quality assessment visits and co-monitoring visits alongside CRAs.

• Organize and facilitate CRA meetings.

• Oversee SQV, SIV, SMV, and COV deliverables, including annotated reports, follow-up letters, and monitoring tools.

• Engage in business development initiatives and mentor junior CTMs as necessary.

• Contribute to improvements in departmental tools and processes.

• Track, forecast, and reconcile project budgets while supporting change orders and financial planning.

• Ensure the timely and budget-compliant delivery of clinical trials.

• Utilize expertise to resolve complex issues and enhance processes.

⛳️ Requirements

• Sufficient experience and qualifications to fulfill assigned responsibilities; specific years of experience are not specified.

• Comprehensive knowledge of the protocol, therapeutic area, and indication.

• Familiarity with clinical monitoring activities, Sponsor contracts, SOPs, ICH/GCP guidelines, regulations, laws, and study-specific requirements.

• Proven experience in identifying quality issues and trends in site performance through KPI reviews, project meetings, site communications, and audit findings.

• Experience in developing and managing corrective action plans and risk mitigation strategies.

• Background serving as a sponsor contact for operational site-specific issues and clinical deliverables.

• Experience in training, mentoring, and supervising CRAs, Lead CRAs, and clinical operations staff.

• Experience in managing site activities, including screening, enrollment oversight, site training, and performance evaluations.

• Familiarity with tracking site visit report metrics and assessing protocol deviations.

• Experience in creating monitoring plans and contributing to study plans, manuals, logs, and site materials.

• Experience in preparing and conducting CRA training sessions, CRA meetings, quality assessment visits, and co-monitoring visits.

• Experience overseeing SQV, SIV, SMV, and COV development, performance, quality, and completion.

• Experience with project budget tracking, forecasting, reconciliation, billed hours, out-of-scope work, change orders, cost justification, and financial planning.

• Ability to proactively identify complex issues, analyze outcomes, and present solutions.

• Must possess a work permit for Europe.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive benefits, including medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, and social activities.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.

• Eligibility for a work permit in Europe.