Sr Site Activation Specialist

You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.

You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.

You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.

Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.

You may also act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.

Requirements:

• Bachelor’s Degree in Life Sciences or related field
• Minimum 4-5 years’ prior experience in Clinical Research, including 1 year in a leadership capacity.
• Experience with activities such as submissions to Ethics Committees and Regulatory Authorities, contract and budget negotiations, study start-up activities, and overall site activation processes.
• Familiarity with the day-to-day responsibilities within Global Site Activation
• Strong problem solving skills
• Ability to negotiate and have strong communication skills
• Ability to work on multiple projects
• Knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and ICH/GCP
• Native-level Czech and advanced English proficiency

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.