Clinical Trial Manager

Job not on LinkedIn

🔥 13 hours ago

🇪🇺 Europe – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 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.

📋 Description

• 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

• 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

• 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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