Clinical Trial Manager II – Early Phase

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🔥 0 minutes ago

🇨🇦 Canada – 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 monitoring deliverables for Early Phase clinical trials • Support the PM, EPTR in overseeing clinical monitoring and ensuring timely, quality deliverables compliant with monitoring plans, budgets, SOPs, regulations, GCP and study requirements • Identify risks, quality issues and trends related to site performance and clinical monitoring activities • Summarize findings and establish corrective action plans • Serve as a point of contact for CRAs and Lead CRAs on assigned projects • Mentor and oversee CRAs and Lead CRAs • Oversee site visit report review and track site visit report metrics • Contribute to Clinical Monitoring Plans and project-specific CRA and site training • Develop annotated site visit reports and monitoring tools • Conduct quality control visits and co-monitoring visits with CRAs • Contribute to CRA meeting content and Clinical Operations project performance indicators • Participate in business development activities, including client meetings, proposal defense meetings, RFPs and RFIs • On selected studies, manage trial timelines, budgets, resources and vendors as primary Sponsor contact • Coordinate tasks and deliverables across functional departments • Control project budgets, review billed time, and identify out-of-scope activities for change orders • Ensure study documents and project deliverables are developed on time and meet study requirements

🎯 Requirements

• B. Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience • At least 5 years of clinical research experience, including prior monitoring experience • At least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or CRO industry • Fluent in English (excellent oral and written) • Strong knowledge of ICH/GCP standards and applicable regulatory requirements • Excellent mastery of Microsoft Office suite (Word, Excel, Power Point) • Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites and sponsors • Excellent leadership, organizational, time management and multi-tasking skills • Excellent judgement and problem-solving skills • Travel up to 30% of the time • Applicants must be legally authorized to work in Canada • Experience in a CRO and in dermatology is an asset

🏖️ Benefits

• Stimulating work environment • Attractive advancement opportunities • Equitable treatment and equal opportunity • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request