Description
The 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 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
- 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.