Study Start Up Manager

Responsibilities

• Direct and manage the delivery of site activation, maintenance, and regulatory activities for clinical studies or multi-protocol programs.
• Oversee execution of site activation and maintenance in accordance with agreed strategies and project timelines.
• Develop, implement, and maintain Management Plans according to the Scope of Work and Project Plan.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development and study initiation.
• Determine regulatory strategy, expectations, and parameters for submissions and necessary authorizations.
• Identify regulatory complexities and offer creative solutions to support the bid process and site activation plans.
• Mentor and coach colleagues while ensuring accurate maintenance of internal systems, databases, and tracking tools.
• Manage study financial aspects, including budget planning and reviews.

Requirements

• Bachelor's Degree in Life Sciences or a related field.
• 7 years of relevant experience in a scientific or clinical environment.
• Demonstrable experience in an international role.
• Thorough understanding of the regulated clinical trial environment and the drug development process.
• Strong knowledge of and ability to apply GCP and ICH guidelines.
• Proven ability to manage multiple projects and balance competing priorities.
• Excellent negotiation, communication, and interpersonal skills.
• Strong organizational, planning, and leadership skills.

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.