(Senior) Site Activation Specialist

IQVIA Argentina; Fatih; On-site; TRY 20,000 - 35,000; Full time

Job summary

A leading global provider of clinical research services is seeking a professional to serve as a Single Point of Contact (SPOC) for investigative sites. The role involves ensuring adherence to SOPs, performing regulatory activities, and maintaining project timelines to support the development of innovative medical treatments.

Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites.
• Ensure adherence to Standard Operating Procedures (SOPs) and project timelines.
• Perform Regulatory Start-up and Maintenance activities.

Job description

Job Responsibilities

1. Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites.

2. Ensure adherence to Standard Operating Procedures (SOPs), work instructions (WIs), quality of designated deliverables, and project timelines.

3. Perform Regulatory Start-up and Maintenance activities according to applicable regulations, SOPs, and WIs.

4. Distribute completed documents to sites and internal project team members.

5. Prepare site regulatory documents, reviewing for completeness and accuracy.

6. Review, prepare, and negotiate site contracts and budgets with sites.

7. Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.

8. Review and provide feedback to management on site performance metrics.

9. Review, establish, and agree on project planning and timelines. Ensure monitoring measures are in place and implement contingency plans as needed.

10. Inform team members of the completion of regulatory and contractual documents for individual sites.

11. Review, track, and follow up on the progress, approval, and execution of documents, including contracts, regulatory, ethics, ICF, and IP release documents in line with project timelines.

12. Provide local expertise to RSU leads and the Project team during initial and ongoing project planning.

13. Perform quality control on documents provided by sites.

14. May have direct contact with Sponsor on specific initiatives.

15. May perform Site Selection Visits if trained as a monitor.

16. May participate in feasibility and site identification activities.

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com