Senior Site Activation Specialist, ICF Lead

Senior Site Activation Specialist, ICF Lead
Location: South Africa, Slovakia, Serbia, Bulgaria
Work Model: Hybrid or Homebased

Job Overview

The Senior Site Activation Specialist, ICF Lead performs country-level Site Activation (SA) activities in compliance with applicable local and international regulations, IQVIA Standard Operating Procedures (SOPs), project requirements, and contractual or budgetary guidelines.

This role is a senior individual contributor position, operating under moderate supervision, with responsibility for managing key start-up deliverables and providing local and regional expertise. The role also contributes to continuous improvement by making recommendations to enhance processes, systems, and operational effectiveness within Site Activation.

Essential Functions

• Under general supervision, act as the Single Point of Contact (SPOC) for assigned studies, collaborating with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other internal stakeholders
• Ensure compliance with local regulations, SOPs, Work Instructions (WIs), quality standards, and agreed project timelines
• Perform feasibility assessments, site identification, study start-up, and site activation activities in line with regional regulatory requirements
• Prepare, review, and distribute site documentation, ensuring completeness, accuracy, and timeliness
• Maintain accurate and up-to-date information in internal systems, databases, and tracking tools
• Review site performance metrics and provide insights and feedback to management
• Review, establish, and align on project plans and timelines, ensuring monitoring measures and contingency plans are implemented when needed
• Communicate completion of feasibility, site identification, regulatory, and contractual milestones to relevant project team members
• Review, track, and follow up on the progress, approval, and execution of study documents, including:
  • Confidential Disclosure Agreements (CDAs)
  • Site Information Forms (SIFs)
  • Regulatory and ethics submissions
  • Informed Consent Forms (ICFs)
  • Investigator Packs (IPs) and IP release documentation
• Provide local regulatory and operational expertise to SAMs and project teams during start-up and throughout study execution
• Perform quality control reviews of documentation received from investigative sites
• Maintain limited and appropriate direct sponsor contact for specific initiatives, as required

Qualifications

• Bachelor’s degree in Life Sciences or a related field (required)
• Minimum of 5 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience
• At least 1 year of experience in a leadership or lead role within clinical research, study start-up, or site activation
• Strong understanding of country-specific regulatory requirements within one or more of the listed locations
• Demonstrated ability to manage multiple priorities, meet deadlines, and work cross-functionally
• Strong communication skills, attention to detail, and problem-solving mindset

Why Join IQVIA

At IQVIA, you will be part of a global organization focused on advancing clinical research and improving patient outcomes. This role offers the opportunity to work in a hybrid model, collaborate with international teams, and contribute to impactful studies across multiple regions.