Global Clinical Project Manager

Pharmaceutical Research Associates, Inc; León; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading global clinical research organization seeks a Global Clinical Project Manager. This permanent, full-time role involves leading trial teams, managing budgets, and ensuring compliance with regulations. Ideal candidates have extensive experience in clinical trial management and strong leadership skills.

Servicios

Health insurance options

Retirement plans

Employee Assistance Programme

Life assurance

Flexible benefits

Formación

• At least 6 years of clinical trial management experience in pharma or CRO.
• Experience leading global or regional teams in a virtual environment for 2-3 years.

Responsabilidades

• Lead the Study Management Team and manage trial progress.
• Ensure compliance with regulations and manage country budgets.
• Coordinate data cleaning and support database lock processes.

Conocimientos

Leadership

Stakeholder Management

Project Management

Analytical Skills

Communication

Educación

BS degree in Life Sciences

Descripción del empleo

As a Global Clinical Project Manager, you will join the world’s largest & most comprehensive clinical research organisation, 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

What you will be doing :

• Lead the Study Management Team, providing updates on deliverable status to all trial team members.
• Ensure the availability of required reports for real-time tracking of trial status according to the trial plan.
• Manage documentation and communication of trial progress.
• Maintain the Study Management Team in a constant state of inspection-readiness.
• Serve as the primary contact for Country and Regional staff and for local teams.
• Partner with the Global Trial Lead to execute and oversee activities from planning through trial close-out.
• Ensure issues are escalated and resolved promptly.
• Work with the Trial Team to ensure CAPAs are addressed timely; act as CAPA owner or contributor as appropriate.
• Contribute to data collection for site selection and participate in feasibility assessments.
• Establish enrollment commitments and ensure actual enrollment meets projections across regions.
• Develop and maintain recruitment and contingency plans for each region.
• Track and file trial data timely in appropriate systems.
• Perform Annual Quality Reviews and ensure proper archiving of documents.
• Manage country budgets, monitor expenses, and oversee vendor deliverables and invoices.
• Create and update trial-specific documents (e.g., Monitoring Guidelines, ICF, IMP documentation, Blinding Plan).
• Provide input for regulatory submissions and develop training materials for trial sites and staff.
• Coordinate Investigator Meetings and maintain relationships with internal stakeholders.
• Ensure compliance with regulations and participate in inspections and audits.
• Coordinate data cleaning and support database lock processes.
• Lead or participate in process improvements and special initiatives.

Qualifications

You are :

• BS degree or equivalent in Life Sciences with at least 6 years of clinical trial management experience in the pharmaceutical industry or CRO.
• Experience in a specific therapeutic area.
• Strong knowledge of ICH-GCP, local laws, and regulations.
• Proven track record in managing trials from start-up to database lock and closure.
• Effective leadership and stakeholder management skills.
• Experience leading global or regional teams in a virtual environment for at least 2-3 years.
• Strong project management skills, proactive risk mitigation, and IT proficiency.
• Proficiency in local language and English, with excellent communication skills.
• Strong analytical skills and ability to manage ambiguity.
• Experience developing presentations and managing budgets.

What ICON can offer you: We prioritize building a diverse culture that rewards high performance and nurtures talent. Benefits include:

• Various leave entitlements.
• Health insurance options.
• Retirement plans.
• Employee Assistance Programme, TELUS Health.
• Life assurance and flexible benefits.

Visit our careers site to learn more about working at ICON. We are committed to diversity, inclusion, and providing an accessible environment for all candidates. We encourage you to apply even if you do not meet every requirement, as you may still be the right fit for this or other roles at ICON.