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Clinical Trial Manager
Innovaderm Research Inc.. Operationally manage and oversee clinical investigative sites and clinical operations deliverables for clinical trials .
About the role
Key responsibilities & impact- Operationally manage and oversee clinical investigative sites and clinical operations deliverables for clinical trials
- Train and oversee CRA activities, including CRA transitions
- Identify quality issues and trends in site performance and establish corrective action plans
- Ensure adherence to study plans, SOPs, ICH/GCP guidelines, regulations, laws, timelines, and budgets
- Serve as primary sponsor contact for site-specific operational issues and clinical deliverables
- Contribute to internal, sponsor, and investigator meetings
- Manage risk assessments and mitigation execution
- Manage site contacts, site training, monitoring performance, screening, and enrollment oversight
- Track site visit report metrics and assess protocol deviations and action items
- Develop the Monitoring Plan and contribute to study plans, manuals, reference materials, logs, and site instructions
- Prepare and conduct CRA training, coordinate and lead CRA meetings, and conduct quality assessment and co-monitoring visits
- Oversee SQV, SIV, SMV, and COV development, performance, quality, and completion
- Participate in business development activities, including client meetings, bid defenses, RFPs, and RFIs
- Contribute to departmental tools and process improvements
- Track, forecast, and reconcile project budgets and support change orders and financial planning
- Proactively identify issues, present solutions, and support delivery of clinical trials within agreed timelines and budgets
- Apply prior experience to solve complex issues, identify solutions, and analyze outcomes
Requirements
What you’ll need- Experience and qualification sufficient to perform assigned responsibilities
- In-depth knowledge of the protocol, therapeutic area, and indication
- Knowledge of ICH/GCP guidelines, regulations, laws, SOPs, and study-specific requirements
- Experience managing clinical monitoring activities and clinical investigative sites
- Experience with site performance, monitoring, KPI reviews, audit findings, and corrective action plans
- Experience developing monitoring plans and other study plans, manuals, reference materials, logs, and site worksheets/instructions
- Experience training, mentoring, and overseeing CRAs, Lead CRAs, and clinical operations staff
- Experience managing site screening, enrollment oversight, site visits, protocol deviations, and risk mitigation
- Experience with clinical trial budgets, forecasting, reconciliation, billed hours, out-of-scope work, and change orders
- Work permit for Europe required
Benefits
Comp & perks- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development
- Attractive advancement opportunities