Clinical Project Manager III – Senior CPM

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Plan, execute, assess, and finalize assigned clinical trials, often serving as the global trial lead.

• Establish objectives and timelines while providing oversight and guidance to clinical trial teams.

• Coordinate the operational aspects of functional areas to ensure compliance with ICH, GCP, regulatory standards, and protocols.

• Manage comprehensive clinical trial projects from initiation through analysis, including global trials.

• Organize project activities and implement the contracted scope of work.

• Evaluate and manage project budgets in relation to milestones and scope, taking corrective actions as necessary.

• Assess project profit margins and create mitigation strategies.

• Evaluate scope against client contracts and facilitate change orders.

• Develop or supervise trial plans, timelines, schedules, resources, budgets, and deliverables.

• Act as the operational-level point of contact for clients.

• Oversee contracted vendors, including specifications, timelines, expectations, and financial expenditures.

• Monitor trial KPIs and mitigate activities that fall outside expected parameters.

• Manage project tracking and ensure timely information entry for accurate client and executive reporting.

• Monitor resource requirements and communicate issues to heads of functional departments.

• Ensure that the clinical trial team is trained for protocol implementation and execution.

• Supervise CRA tasks, site management, monitoring of clinical trial data, site trip reports, and escalation of site issues.

• Attend site visits as necessary.

• Lead client and team meetings, documenting discussions, decisions, and outcomes.

• Prepare or oversee the creation of project status reports.

• Plan and manage investigator meetings, including agendas, materials, and presentations.

• Maintain and audit the Trial Master File (TMF) for assigned studies.

• Engage in business development activities, including RFP development, bid defense presentations, and client meetings.

• Lead or take part in process improvement initiatives.

• Mentor other CPM staff members.

• Review site and vendor invoices, approving subject milestone payments as required by region.

• Assist with payment projections and maintaining payment records.

• Support or conduct regional site budget negotiations.

• In the EU, coordinate with the EU Clinical Trial Budget Management Team, regional CRAs, and Study Start-up Specialists regarding site budgets, payments, invoices, and country-specific communications.

⛳️ Requirements

• Bachelor's degree in allied health fields such as nursing, pharmacy, or health science, ideally with clinical trial management experience, or a comparable combination of education and relevant work experience.

• Minimum of 6 years of clinical research experience, including roles as CRO CRA, Research Manager, Site Research Manager, or Central Clinical Research Laboratory Manager, or applicable project management skills and experience in a clinical or related industry.

• Proficiency in English.

• Capability to plan, implement, assess, and finalize the full execution of assigned clinical trials.

• Ability to manage global clinical trial projects from initiation through to analysis.

• Knowledge of ICH guidelines, GCP, applicable regulatory guidelines, and trial procedures.

• Capacity to manage multiple projects concurrently.

• Proficiency in managing project budgets, milestones, scope, profit margins, and vendor financial expenditures.

• Ability to oversee clinical trial teams, CRAs, sites, vendors, and ensure TMF completeness.

• Competence in utilizing computer-assisted project tracking programs.

• Ability to support or conduct site budget negotiations and manage site payments as regionally required.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing education support.

• Hybrid work opportunities.

• CTI Cares initiatives to contribute to the community and the world.

• Support for work-life balance.

• Award-winning culture that prioritizes people.