Site Activation Specialist

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work

• Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

• Prepare site documents, reviewing for completeness and accuracy.

• 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 feasibility, site ID, regulatory and contractual documents for individual sites.

• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's Degree

• This role is primarily focused on site maintenance activities for active clinical trial sites rather than initial site activation/start-up.

• Experience in Clinical Research, including site maintenance, CRA, Study Coordinator is preferred.

• Ability to communicate effectively in English, including participation in teleconferences and preparation of written communications with global teams and sponsors.

• Hands-on experience managing IRB submissions and maintenance activities, such as protocol amendments, continuing reviews, site documentation updates, and other regulatory requirements.

• Experience with clinical trial budget/contract amendments and maintenance-related negotiations is preferred.

• Ability to independently manage ongoing site maintenance activities, ensuring compliance with regulatory, sponsor, and institutional requirements.

• Strong problem-solving and stakeholder management skills, with the ability to drive issue resolution in collaboration with internal and external partners.

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.