Study Start Up Manager (SSUM) Belgium

Responsibilities

• Oversee the execution of site activation and maintenance for assigned projects in accordance with agreed strategies and timelines.
• Develop, implement, and maintain management plans according to the scope of work and project plan.
• Ensure collaboration across regulatory and site activation teams to deliver project scope in compliance with management plans.
• Create and review technical and administrative documentation to support business development and study initiation.
• Provide guidance and oversight of multi-regional and multi-protocol programs during the start-up and maintenance phases.
• Determine regulatory strategies, expectations, and parameters for submissions and necessary authorizations.
• Identify regulatory complexities and offer practical solutions to support the bid process and site activation plans.
• Execute operational strategies for the maintenance of clinical study approvals, authorizations, and contract negotiations.
• Maintain accurate internal systems, including CTMS, databases, tracking tools, and project plans.

Requirements

• Bachelor's Degree in Life Sciences or a related field.
• 7 years of relevant experience in a scientific or clinical environment.
• Demonstrable experience working in an international role.
• Thorough understanding of the regulated clinical trial environment and the drug development process.
• Proficiency in applying Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong technical and regulatory writing skills.
• Demonstrated proficiency in using systems and technology to achieve work objectives.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.