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Global Site Activation Specialist
hace 2 meses
About the Role
We are seeking a highly skilled and experienced Global Site Activation Specialist to join our team at IQVIA. As a key member of our team, you will be responsible for managing and executing site identification processes, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.
Key Responsibilities
- Manage and execute site identification processes, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.
- Prepare and manage site regulatory documentation, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish, and agree on project planning and project timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to Site Activation Managers and project team during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
Requirements
- Bachelor's Degree in Business or Science/Healthcare or Nursing field.
- 2-3 years of experience within the clinical research industry, with regulatory and start-up/site activation experience highly valued.
- Advanced level of English skills.
