Global Clinical Start-Up Lead: Site Activation & Regulatory

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

Job summary

IQVIA in Durham, NC seeks a results-driven professional to direct and manage site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award tasks and budget oversight.

The role requires coordinating with Regulatory & Site Activation teams across regions, providing regulatory and technical support for trials, and ensuring compliance with GCP/ICH guidelines while steering contracts and essential documents to timely study start-up and

Qualifications

• Bachelor's Degree in life sciences or related field
• Minimum 7 years' relevant experience in scientific/clinical environments, including international roles
• Strong negotiation and communication skills
• Excellent interpersonal and teamwork abilities
• Understanding of regulated clinical trial environment and drug development
• Proficiency with CTMS and related systems
• Knowledge of GCP/ICH guidelines
• Ability to manage budgets and contracts

Responsibilities

• Oversee site activation and maintenance per RSU strategy and project plan
• Develop and maintain the Management Plan and project timelines
• Collaborate with Regulatory & Site Activation across regions
• Provide regulatory and technical scientific support for trials
• Lead relationships with IQVIA customers

Skills

Negotiation

Communication

Interpersonal skills

Leadership

Organizational skills

Multi-project management

Regulatory/ICH/GCP knowledge

Education

Bachelor's Degree Life sciences or related field

Tools

CTMS

Job description

IQVIA in Durham, NC seeks a results-driven professional to direct and manage site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award tasks and budget oversight.

The role requires coordinating with Regulatory & Site Activation teams across regions, providing regulatory and technical support for trials, and ensuring compliance with GCP/ICH guidelines while steering contracts and essential documents to timely study start-up and