Senior Clinical Project Manager

This is a fully remote position, open to applicants in United Kingdom, +1 more state.

📋 Description

• Plan, implement, assess, and successfully execute assigned clinical trials, frequently acting as a global trial lead.

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

• Coordinate the operational elements of functional areas to ensure adherence to ICH, GCP, regulatory guidelines, and trial procedures.

• Oversee comprehensive clinical trial projects from initiation to analysis, including global studies.

• Manage multiple projects and the team members assigned functionally.

• Execute project activities in accordance with the contracted scope.

• Evaluate and manage project budgets, milestones, scope, and profit margins.

• Review contractual scope and facilitate change-of-scope orders as necessary.

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

• Act as the client contact at the operational level of the project.

• Supervise contracted vendors and monitor third-party vendor financial expenditures.

• Track trial KPIs and implement mitigation strategies as needed.

• Ensure project tracking and prompt data entry for precise reporting.

• Monitor resource requirements and communicate any resource or performance concerns.

• Ensure adequate training for assigned clinical trial teams.

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

• Attend site visits as required.

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

• Prepare or supervise the creation of project status reports.

• Plan and oversee Investigator meetings and presentations.

• Ensure the completeness, accuracy, and maintenance of the TMF, and conduct regular audits.

• 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 regionally required.

• Assist with payment projections, payment records, site budget negotiations, and regional site payment activities.

⛳️ Requirements

• Bachelor’s degree in an allied health field such as nursing, pharmacy, or health science, or an equivalent combination of education and relevant work experience.

• A minimum of 6 years of clinical research experience in a CRO, CRA, research management, site research management, or central clinical research laboratory management; alternatively, transferable project management experience in a clinical or related field.

• Preferred experience in clinical trial management.

• Proficiency in English.

• Ability to plan and manage comprehensive clinical trials from initiation through analysis.

• Capability to handle multiple projects concurrently.

• Knowledge of ICH guidelines, Good Clinical Practices, applicable regulatory standards, and trial procedures.

• Experience managing clinical trial budgets, milestones, scopes, profit margins, and change orders.

• Experience supervising clinical trial teams, CRAs, sites, vendors, and third-party financial expenditures.

• Ability to manage and audit the Trial Master File.

• Competence in leading client, team, and Investigator meetings.

• Ability to prepare or oversee trial plans, timelines, schedules, resources, budgets, deliverables, and status reports.

• Capability to support business development activities and process improvement initiatives.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing education support.

• Hybrid work opportunities.

• CTI Cares community and world impact opportunities.

• Award-winning culture prioritizing people.

• Support for work-life balance.

• Opportunity to contribute to life-changing treatments for patients.