Senior Clinical Project Manager – Early Phase

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Take charge and supervise Phase I and initial development clinical trials from the initiation stage to closeout.

• Act as the main point of contact for sponsors and internal stakeholders.

• Direct assigned early-phase clinical trials from study initiation through to database lock and closeout.

• Serve as a liaison among sponsors, internal teams, vendors, and study sites.

• Create and manage project timelines, milestones, resources, risks, finances, and deliverables.

• Ensure projects adhere to contractual obligations, study protocols, operational plans, quality standards, timelines, and budget expectations.

• Lead cross-functional project teams and coordinate activities among internal departments and external partners.

• Oversee project budgets, forecasting, change orders, scope, risks, issues, and resource needs.

• Formulate contingency plans and risk mitigation strategies.

• Deliver project status updates and reports to clients and senior leadership.

• Guarantee compliance with GCP, ICH guidelines, company SOPs, and regulatory mandates.

• Manage the quality, completeness, and readiness for inspection of the Trial Master File.

• Keep study information updated in CTMS and other clinical systems.

• Assist with audit and inspection readiness activities.

• Maintain project documentation and assigned study deliverables.

• Cultivate sponsor relationships through effective communication and successful delivery.

• Lead governance, study team, internal, and external project meetings.

• Present updates, risks, mitigation strategies, and milestones to clients and executive stakeholders.

• Participate in bid defense meetings and aid in business development efforts.

• Identify avenues for future business and enhanced client partnerships.

• Provide leadership and guidance to cross-functional study teams.

• Promote collaboration and accountability across operational functions.

• Mentor junior team members and clinical operations staff.

• May have line management responsibilities for project management and clinical monitoring personnel.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific field; or a comparable combination of education and experience.

• A minimum of 5+ years of clinical research experience with increasing project management responsibilities.

• Proven experience in managing Phase I and/or early-phase clinical trials.

• Strong understanding of GCP, ICH guidelines, and global regulatory standards.

• Demonstrated capability to manage multiple projects within a fast-paced clinical research environment.

• Solid financial management and budget oversight skills.

• Exceptional organizational, problem-solving, and risk management abilities.

• Excellent verbal and written communication, presentation, and stakeholder management capabilities.

• Ability to work independently while effectively leading cross-functional teams.

• Proficient with CTMS, eTMF, and related clinical trial technologies.

• Willingness to travel approximately 25% of the time.

• Preferred: Experience within a Contract Research Organization (CRO).

• Preferred: Direct experience with First-in-Human (FIH), SAD, MAD, clinical pharmacology, or proof-of-concept studies.

• Preferred: Experience managing studies with healthy volunteers, specialty, and/or patient populations.

• Preferred: Vendor management and oversight experience.

• Preferred: Previous leadership or line management experience.

• Preferred: Experience with decentralized and technology-enabled clinical trials.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition program.

• Total rewards program.

• Inclusive organizational culture.

• Reasonable accommodations available when necessary.