Global Study Start-Up Manager

IQVIA; Durham (NC); On-site; USD 75,000 - 216,000; Full time

Job summary

IQVIA is seeking a Site Activation and Regulatory Lead to direct site activation, maintenance and regulatory activities for studies. You will oversee pre-award activities, budgets, resources and ensure alignment with the RSU Management Plan.

Responsibilities include coordinating with Regulatory & Site Activation teams globally, supporting business development, providing regulatory and technical guidance, and maintaining CTMS and project plans to enable timely study initiation and ongoing

Qualifications

• Bachelor's degree in life sciences or related field.
• 7 years’ experience in scientific or clinical environment, international role preferred.
• Strong negotiation and communication skills with ability to challenge.
• Regulatory writing skills and knowledge of GCP/ICH guidelines.
• Ability to manage multiple projects, timelines and budgets.

Responsibilities

• Direct site activation, maintenance and regulatory activities for studies.
• Oversee pre-award activities, budget, scope of work and resources.
• Coordinate regulatory strategy and submissions with multi-regional teams.
• Mentor colleagues and ensure quality standards and CTMS use.

Skills

Negotiation

Communication

Teamwork

Leadership

Education

Bachelor's Degree Life sciences or related field

Job description

IQVIA is seeking a Site Activation and Regulatory Lead to direct site activation, maintenance and regulatory activities for studies. You will oversee pre-award activities, budgets, resources and ensure alignment with the RSU Management Plan.

Responsibilities include coordinating with Regulatory & Site Activation teams globally, supporting business development, providing regulatory and technical guidance, and maintaining CTMS and project plans to enable timely study initiation and ongoing