Senior Site Activation Specialist, ICF Lead

IQVIA; Bellville; Hybride; ZAR 600 000 - 900 000; Temps partiel

Résumé du poste

IQVIA is seeking a Senior Site Activation Specialist, ICF Lead to drive country-level SA activities in South Africa, Slovakia, Serbia, and Bulgaria. Hybrid or homebased role requiring strong regulatory and start-up expertise.

You will act as SPOC for assigned studies, coordinate with SAMs, PMs, and sites, ensure timelines, quality, and compliance, and contribute to process improvements across regions.

Qualifications

• Bachelor’s degree in Life Sciences or a related field is 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.

Responsabilités

• Act as the Single Point of Contact (SPOC) for assigned studies, collaborating with investigative sites, Site Activation Managers, Project Management teams, and other internal stakeholders.
• Ensure compliance with local regulations, SOPs, Work Instructions, 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 (CDAs, SIFs, regulatory and ethics submissions, ICFs, IPs, 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.

Connaissances

Communication

Leadership

Problem-solving

Multitasking

Formation

Bachelor’s degree in Life Sciences or related field

Outils

Regulatory databases

Description du poste

Bellville, South Africa

Belgrade, Serbia

Sofia, Bulgaria

Part time

R1563629

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.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled