Regulatory and Start Up Manager, Sponsor Dedicated

Responsibilities

• Manage a department or work unit responsible for site activation activities.
• Set goals and objectives for team members to achieve short-term operational and tactical results.
• Plan, assign, and direct work while assessing performance and guiding professional development.
• Oversee the hiring, onboarding, and training of new employees to ensure proper system access and SOP compliance.
• Allocate resources to clinical research projects by assigning staff based on experience and training.
• Monitor work quality through regular reviews and implement corrective action plans to address performance deficiencies.
• Ensure staff meet defined workload and quality metrics through regular reporting.
• Lead process and system improvements to enhance the performance of the job area.

Requirements

• Minimum of 5–6 years of experience in start-up or site activation.
• Proven experience as an RSU Lead or Site Activation Lead.
• Bachelor's Degree in a scientific discipline or healthcare field preferred.
• Fluency in English (written and verbal) is required.
• Strong knowledge of GCP/ICH and applicable regulatory guidelines.

Preferred Qualifications

• Experience as a CRA Manager, Clinical Lead, Project Lead, Start-up Manager, Site Activation Manager, or Regulatory Affairs (RA) specialist.
• Strong knowledge in budgeting, contract review, and project financial management.

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.