Senior Project Manager, Early Phase and Translational Research

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🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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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

• Oversee and manage domestic, regional, and/or international clinical research projects • Develop and manage project teams, communications, risks, scope, schedules, costs, quality, and stakeholders • Serve as the primary contact for sponsors, sites, CRAs, vendors, and internal teams • Lead clinical trial initiation, planning, execution, monitoring, control, and closure • Provide input to feasibility, study design, budget development, and progress reporting • Ensure assigned studies remain audit ready • Serve as escalation point for project issues and proactively resolve conflicts • Manage trial timelines, budgets, resources, vendors, and cross-functional tasks and deliverables • Control project budgets, review billed time, and identify out-of-scope activities for change orders • Provide trial progress updates and manage KPIs, resources, and succession plans • Lead study start-up, including kick-off meetings, TMF setup, site selection and activation, vendor setup, contracting, and budgeting • Manage risks and quality controls; escalate issues to management, quality assurance, and sponsors • Lead client, internal work group, and vendor meetings; distribute and file meeting minutes • Monitor study deliverables and implement corrective actions and quality improvements • Maintain project-specific training matrices and review training records • Review and approve responses to quality assurance audits • Ensure study documents and project deliverables are timely and compliant • Oversee TMF filing, maintenance, and archival procedures • Manage and report recruitment status and mitigation initiatives • Participate in Investigator Meetings • Collaborate with Regulatory Affairs on submissions and essential documents • Oversee clinical monitoring activities and contribute to the Clinical Monitoring Plan • Train CRAs and potentially perform study initiation visits • Develop site visit reports and monitoring tools • Support sites with investigational products, supplies, equipment, and safety lab kits • Collaborate with Data Management on CRF compliance, query resolution, data review, and database lock • Mentor team members and contribute to training, process improvement, and business development presentations

🎯 Requirements

• B.Sc. in a related field of study to clinical research • At least 7 years industry experience • Minimum 5 years in Phase I-III clinical trial project management with financial accountability • Experience leading concurrent multi-centered, multinational clinical trials with budgets in excess of $25M USD • PMP certification desirable • Experience in cost management, study start-up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management considered an asset • Therapeutic experience managing dermatology trials an asset • Excellent knowledge of GCP and ICH standards, FDA and local country regulations • Excellent knowledge of Microsoft Office suite • Fluency in English with excellent oral and written skills required • Bilingualism (English and local language) is an asset • Ability to work in a team environment and establish good relationships with colleagues and sponsors • Good problem-solving abilities • Strong ability to carry out different projects and work under pressure while meeting timelines • Good knowledge of applicable Health Canada and FDA regulations/guidelines • Must be legally authorized to work in Canada

🏖️ Benefits

• Stimulating work environment • Attractive advancement opportunities • Home-based position in Canada • Equal opportunity and disability accommodations throughout recruitment and selection, upon request