Senior Site Activation Specialist, ICF Lead

About the role

The Senior Site Activation Specialist, ICF Lead is responsible for country‑level site activation activities, ensuring compliance with local and international regulations, IQVIA SOPs, and project requirements. This senior individual contributor works under moderate supervision and serves as the single point of contact for assigned studies.

Key responsibilities

• Act as the Single Point of Contact (SPOC) for assigned studies, collaborating with investigative sites, Site Activation Managers, Project Management teams, and internal stakeholders.
• Ensure compliance with local regulations, SOPs, work instructions, quality standards, and 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, maintaining accuracy and timeliness.
• Maintain up‑to‑date information in internal systems, databases, and tracking tools.
• Review site performance metrics and provide insights to management.
• Establish and align project plans and timelines, implementing monitoring measures and contingency plans.
• Communicate completion of feasibility, site identification, regulatory, and contractual milestones.
• Track and follow up on study documents such as CDAs, SIFs, regulatory submissions, ICFs, Investigator Packs, and IP release documentation.
• Provide local regulatory and operational expertise to SAMs and project teams throughout study execution.
• Perform quality control reviews of documentation received from investigative sites.

Required profile

• Bachelor’s degree in Life Sciences or a related field.
• Minimum of 5 years of clinical research or relevant 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 for the listed locations.
• Demonstrated ability to manage multiple priorities, meet deadlines, and work cross‑functionally.
• Excellent communication, attention to detail, and problem‑solving mindset.

Required skills