As a Global Clinical Project Manager, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. This is a permanent, full-time role through ICON on FSP, dedicated to a global pharma, and fully home-based.
You must currently be working as a Global Clinical Project Manager within a CRO or Pharma setting, with strong vendor management experience.
Responsibilities:
- Lead the Study Management Team, providing updates on deliverable status.
- Ensure the availability of reports supporting real-time trial status tracking.
- Manage documentation and communication of trial progress.
- Maintain inspection-readiness of the Study Management Team.
- Act as primary contact for Country and Regional staff.
- Partner with the Global Trial Lead to oversee trial activities from planning to close-out.
- Ensure issue escalation and resolution.
- Work with Trial Team to resolve CAPAs timely, acting as owner or contributor.
- Contribute to site selection data collection.
- Participate in feasibility assessments and provide recommendations.
- Establish and monitor enrollment commitments and contingency plans.
- Track and file trial data appropriately.
- Perform annual quality reviews and ensure proper archiving.
- Manage country budgets and monitor expenses.
- Oversee vendors and review invoices/spend.
- Create and update trial-specific documents and training materials.
- Coordinate Investigator Meetings and maintain stakeholder relationships.
- Ensure protocol and procedure knowledge, compliance, and participate in audits.
- Coordinate data cleaning and support database lock processes.
- Contribute to process improvements and special initiatives.
Qualifications:
- BSc in Life Sciences or equivalent, with at least 6 years of clinical trial management experience in the pharmaceutical industry or CRO.
- Experience in specific therapeutic areas.
- Strong knowledge of ICH-GCP, local laws, and regulations.
- Proven operational knowledge in clinical research, managing trials from start-up to closure.
- Effective leadership and stakeholder management skills.
- Experience in leading virtual, global or regional teams for at least 2-3 years.
- Strong project management, planning, and risk mitigation skills.
- Proficiency in Microsoft Office, Trial Master File, CTMS, and willingness to learn new systems.
- Monitoring experience or relevant data management/central monitoring experience is recommended.
- Fluent in local language and English, with excellent communication skills.
- Strong analytical skills and ability to manage ambiguity.
- Experience in developing presentations and stakeholder communication.
- Understanding of country-specific budget and cost drivers.
ICON offers competitive salaries, benefits focused on well-being, work-life balance, and diversity and inclusion initiatives. Benefits include leave entitlements, health insurance, retirement plans, Employee Assistance Program, life assurance, and various country-specific benefits.