
201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
đĽ 13 hours ago
đŞđş Europe â Remote
â° Full Time
đĄ Mid-level
đ Senior
đ§Ş Clinical Research
đť Ghost score 12%
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201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
⢠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
⢠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
⢠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
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