Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a Global Study Manager (GSM), you'll be fully integrated into the FSP's clinical operations team, helping to deliver innovative, global clinical studies. You'll ensure projects are completed on time, within budget, and to the highest quality standards, working closely with both internal teams and external partners.
Responsibilities:
- Support the planning, setup, execution, and close-out of global clinical studies.
- Oversee vendors and country teams to ensure smooth study delivery.
- Work closely with internal teams and external partners.
- Help develop and update study documents (e.g., protocols, informed consent forms).
- Manage third-party vendors, including contracts and budgets. Ensure all study activities comply with regulations (ICH-GCP), SOPs, and best practices. Contribute to meetings, audits, and inspections. Support risk management and quality assurance efforts. Maintain accurate study documentation and ensure inspection readiness at all times.
Requirements:
- Bachelor's degree (preferably in life sciences or related field).
- At least 5 years' experience in clinical research, with 3+ years in Global clinical project management/ Global Study Manager within a Pharma or CRO.
- Strong knowledge of clinical research regulations (ICH-GCP).
- Proven ability to deliver projects on time, within budget, and to quality standards.
- Experience working with internal teams and external vendors including vendor set up, management and vendor budgets.
- Excellent communication, teamwork, and problem-solving skills.
- Ability to manage multiple priorities and work in a matrix environment.
- Experience in all phases of clinical study lifecycle.
- Experience in using AI automation in daily work as a GSM.
- Knowledge of GXP outside of GCP (e.g., GMP, GLP).
Benefits:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.