Senior Project Manager, Early Phase and Translational Research

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage and oversee domestic, regional, and/or international clinical research projects.

• Create and lead project teams, handle communications, risks, scope, scheduling, costs, quality, and stakeholder engagement.

• Ensure the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials.

• Act as the primary point of contact for stakeholders.

• Contribute to feasibility assessments, study design, budget planning, and progress reporting.

• Mentor and train other project managers while contributing to ongoing departmental improvements.

• Serve as the main liaison for sponsors, sites, CRAs, vendors, and internal teams.

• Maintain assigned studies in an audit-ready state, including training records, central files, and system validation.

• Act as an escalation point for project-related issues and proactively address conflicts.

• Manage clinical trial timelines, budgets, resources, vendors, and cross-functional deliverables.

• Oversee project budgets, review billed hours, and identify out-of-scope activities for change orders.

• Provide updates on trial progress, covering site and vendor selection, project plans, budgets, timelines, quality, and risk mitigation.

• Develop and monitor project performance metrics to ensure KPIs stay within the contract scope.

• Define resource needs for projects and develop succession plans.

• Lead study start-up activities, including kick-off meetings, TMF setup, site selection, activation, vendor setup, contracting, and budgeting.

• Manage risks and implement control measures to ensure project quality.

• Facilitate client calls, internal work groups, and vendor status meetings, ensuring minutes are documented in the TMF.

• Monitor the quality of study deliverables and address any quality concerns.

• Analyze planned versus actual outcomes and implement necessary corrective actions.

• Maintain study-specific training matrices and review training records.

• Review and approve responses to quality assurance audits.

• Ensure study documents and deliverables are created on schedule and meet all requirements.

• Guarantee that project documentation is properly filed, maintained, and archived in the TMF.

• Provide status updates that comply with budgets, scope, timelines, SOPs, GCP, regulatory, and study-specific requirements.

• Manage and report on recruitment status and mitigation strategies.

• Participate in Investigator's Meetings.

• Collaborate with Regulatory Affairs for timely submissions and essential document management.

• Oversee clinical monitoring activities, including CRA training, monitoring reports, follow-up letters, and site issue escalation.

• Contribute to the Clinical Monitoring Plan.

• Prepare and deliver CRA training and may conduct single-site study initiation visits.

• Develop annotated site visit reports and monitoring tools.

• Support CRAs and Lead CRAs as the main project contact.

• Assist sites with investigational products, supplies, equipment, and safety lab kits.

• Work with data management on CRF compliance, query resolution, and data review through database lock.

• Prepare and present proposals for new business opportunities.

• Offer technical, therapeutic, and project management expertise in training and process enhancement.

• Perform additional assigned responsibilities when qualified and adequately trained.

⛳️ Requirements

• Bachelor's degree in a related field of clinical research.

• Minimum of 7 years of industry experience.

• At least 5 years in Phase I-III clinical trial project management with financial accountability.

• Proven experience in leading concurrent multi-center, multinational clinical trials with budgets exceeding $25M USD.

• PMP certification is preferable.

• Experience in cost management, study start-up, regulatory submissions, resource management, supervisory roles, CRA, data management, medical writing, or vendor management is an asset.

• Therapeutic experience in managing dermatology trials is advantageous.

• Strong understanding of GCP and ICH standards, along with FDA and local country regulations.

• Proficient in Microsoft Office suite.

• Fluent in English with excellent oral and written communication skills; bilingualism (English and local language) is a plus.

• Ability to work effectively in a team environment and foster positive relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Excellent capacity to manage multiple projects and perform under pressure while meeting deadlines.

• Good knowledge of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must be legally authorized to work in the United States.

🏝️ Benefits

• Engaging work environment.

• Attractive opportunities for career advancement.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.