Site Activation & Regulatory Lead (Clinical Trials)

IQVIA; Durham (NC); On-site; USD 48,000 - 157,000; Full time

Job summary

IQVIA is seeking a Site Activation professional to manage site startup activities at the country level, ensuring regulatory and contract documents are completed on time. You will serve as a SPOC for sites, SAMs, and PM teams, coordinating across departments to keep projects on track.

The role requires 3 years of clinical research experience, leadership experience, and strong knowledge of GCP/ICH regulations. Excellent communication and organization are essential.

Qualifications

• Bachelor's degree in life sciences or related field; 3 years clinical research experience.
• 1 year of leadership experience in a trial setting.
• In-depth knowledge of clinical systems, procedures, and regulatory standards (GCP/ICH).
• Knowledge of regulatory requirements including local regulations and SOPs.
• Strong negotiation and communication skills with the ability to challenge when needed.
• Ability to work independently and prioritize tasks; manage multiple projects.

Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for sites, SAM, PM team, and others.
• Perform start up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents and review for completeness.
• Maintain internal systems, databases and tracking tools with project data.
• Review site performance metrics and provide feedback to management.
• Plan project timelines and ensure monitoring measures and contingencies.
• Inform team of completion of regulatory and contract documents.
• Oversee document approval and release timelines; support SAMs and project teams.
• Provide local expertise during initial and ongoing project planning.
• Perform quality control of documents provided by sites.
• Direct contact with sponsors on specific initiatives.

Skills

Negotiation

Communication

Organizational skills

Interpersonal skills

Independence

Time management

GCP/ICH knowledge

Education

Bachelor's degree in life sciences

Clinical research experience (3 years)

Job description

IQVIA is seeking a Site Activation professional to manage site startup activities at the country level, ensuring regulatory and contract documents are completed on time. You will serve as a SPOC for sites, SAMs, and PM teams, coordinating across departments to keep projects on track.

The role requires 3 years of clinical research experience, leadership experience, and strong knowledge of GCP/ICH regulations. Excellent communication and organization are essential.