Sr. Site Activation Specialist

IQVIA Tıbbi İstatisti Tic ve Müş. Ltd. Şti. (TR01); Fatih; On-site; TRY 150,000 - 300,000; Full time

Job summary

A leading clinical research organization in Turkey is looking for a professional to serve as Single Point of Contact (SPOC) in assigned studies. The role involves ensuring adherence to SOPs, performing regulatory start-up activities, and coordinating site contracts. Candidates should have a background in clinical research and project management. This position offers an opportunity to contribute to innovative medical treatments and improve patient outcomes.

Qualifications

• Experience in clinical research or project management is preferred.
• Understanding of regulatory guidelines and SOPs.
• Ability to manage multiple priorities and projects effectively.

Responsibilities

• Serve as Single Point of Contact (SPOC) for investigative sites.
• Ensure adherence to SOPs and quality of deliverables.
• Perform Regulatory Start-up and Maintenance activities.

Skills

Communication Skills

Attention to Detail

Project Management

Job description

Responsibilities

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


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


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


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


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


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


• 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. Ensure monitoring measures are in place and implement contingency plan as needed.


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


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


• Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.


• Perform quality control of documents provided by sites.


• May have direct contact with Sponsor on specific initiatives.


• May perform Site Selection Visits if a trained monitor.


• May participate in feasibility and/or site identification activities.

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