Site Activation & Regulatory Specialist

IQVIA

North Carolina

On-site

USD 60,000 - 157,000

Full time

9 days ago

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Job summary

IQVIA is seeking a Site Activation professional to oversee country-level activation activities in line with regulations and SOPs. You will serve as the primary contact for investigative sites, SAMs, and project teams to ensure timely activation and documentation.

Responsibilities include preparing regulatory documents, maintaining systems, monitoring timelines, and providing local expertise during planning.

Qualifications

Bachelor’s degree or equivalent required.
3 years clinical research experience, incl. 1 year in leadership.
In-depth knowledge of clinical systems, procedures and standards.
Strong negotiating and communication abilities.
Effective organizational and interpersonal skills.
Ability to work independently and prioritize tasks.
Capable of managing multiple projects.
GCP/ICH and regulatory guidelines knowledge.
Familiarity with local regulatory requirements.
Understanding of regulated clinical trials and drug development.

Responsibilities

Serve as SPOC for sites, SAMs, and project teams while ensuring SOPs/WIs are followed.
Perform site startup and activation per regulations; distribute docs to sites and teammates.
Prepare site regulatory documents and ensure completeness.
Maintain internal systems and tracking tools with project data.
Review site performance metrics and provide feedback to management.
Plan timelines and monitoring measures; implement contingency plans.