Global Clinical Trial Manager

Global Study Manager — Role Overview

The Global Study Manager (GSM) will join a global CRO in a sponsor dedicated role, and will be a core member of the extended global study team working on Phase I Haematology Studies. The GSM supports the end-to-end delivery of clinical studies — from protocol development through study set-up, execution, close-out, Clinical Study Report (CSR) development, and archiving — ensuring delivery to time, cost, and quality standards.

Working cross-functionally with internal and external partners, the GSM operates under the direction of the Global Study Director or Global Study Associate Director, executing delegated responsibilities in line with the Delivery Model, Project Management Framework, ICH GCP, applicable SOPs, and company values.

Key Responsibilities:

• Lead or contribute to the preparation of study documents, including Informed Consent Forms, Clinical Study Agreements, and external service provider materials such as specifications, procedures, and presentations.
• Maintain effective relationships with internal functions and external partners, including CROs, to support efficient study delivery against time, cost, and quality objectives.
• Support the planning and execution of internal and external meetings, including Investigators' and Monitors' meetings.
• Coordinate investigational product and study material supply in collaboration with Clinical Supply Chain or external service providers.
• Proactively identify risks and issues, contributing to the development and implementation of mitigation and action plans.
• Ensure all study documents within the GSM's remit are complete, quality-verified, and properly maintained in the Trial Master File.
• Support the GSD/GSAD with budget management activities, including external service provider invoice reconciliation.
• Maintain compliance with global clinical processes, procedural documents, Quality & Compliance requirements, and ICH/GCP guidelines to ensure inspection readiness at all times.
• Provide broader project management support to the GSD/GSAD as delegated.
• For outsourced studies, support the GSD/GSAD in managing the CRO Project Manager to ensure delivery against agreed timelines, budget, and quality standards, maintaining and documenting appropriate CRO oversight throughout the study lifecycle in accordance with relevant SOPs and guidelines.
• Contribute to process improvement initiatives and non-drug project work as agreed with their manager.

Candidate Requirements:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Haematology experience preferred, alongside oncology, rare diseases, or other complex therapeutic areas.
• Phase I experience essential.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently
• Demonstrated leadership skills