Clinical Trial Manager II, Dermatology – Rheumatology

Job not on LinkedIn

🔥 9 minutes ago

🇪🇺 Europe – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

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 and manage CRA transitions • Identify and manage site-performance and monitoring quality issues • Ensure adherence to study plans, timelines, budgets, SOPs, ICH/GCP guidelines, regulations, laws, and study-specific requirements • Review KPIs, project meetings, site communications, and audit findings to identify trends and establish corrective action plans • Serve as primary sponsor and project-team contact for clinical operations matters and deliverables • Contribute to internal, sponsor, and investigator meetings • Manage risk assessments and mitigation execution • Maintain site contact lists, coordinate site training, and oversee site screening and enrollment • Track site visit report metrics and assess protocol deviations and action items • Develop monitoring plans and contribute to study plans, manuals, reference materials, logs, and site worksheets/instructions • Prepare and conduct project-specific CRA training • Conduct quality assessment visits and co-monitoring visits with CRAs • Coordinate and lead CRA meetings • Oversee SQV, SIV, SMV, and COV deliverables, including annotated reports, follow-up letters, and monitoring tools • Participate in business development activities and mentor junior CTMs as applicable • Contribute to departmental tools and process improvements • Track, forecast, and reconcile project budgets and support change orders and financial planning • Support delivery of clinical trials within agreed timelines and budgets • Apply expertise to solve complex issues and improve processes

🎯 Requirements

• Experience and qualifications sufficient to perform assigned responsibilities; specific years of experience are not stated • In-depth knowledge of the protocol, therapeutic area, and indication • Knowledge of clinical monitoring activities, Sponsor contracts, SOPs, ICH/GCP guidelines, regulations, laws, and study-specific requirements • Experience identifying quality issues and trends in site performance through KPI reviews, project meetings, site communications, and audit findings • Experience developing and managing corrective action plans and risk mitigation • Experience serving as a sponsor contact for operational site-specific issues and clinical deliverables • Experience training, mentoring, and overseeing CRAs, Lead CRAs, and clinical operations staff • Experience managing site activities, screening, enrollment oversight, site training, and site performance • Experience tracking site visit report metrics and assessing protocol deviations • Experience developing monitoring plans and contributing to study plans, manuals, logs, and site materials • Experience preparing and conducting CRA training, 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 have a work permit for Europe

🏖️ 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 • Work permit eligibility for Europe