Senior Site Activation Specialist, Regulatory Expert

Senior Site Activation Coordinator, Regulatory Specialist

Country Site Activation

IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies meaning a vast amount of career development opportunities are available.

Our (Senior) Site Activation Specialists perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. You may also be involved in maintenance activities

Job Overview:

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 Instructions (WIs), quality of designated deliverables and project timelines

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

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

Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed

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

Requirements:

• Bachelor’s Degree in Life Science or related field
• Minimum 3 years’ prior experience in life sciences or similar.
• Fluent/ native language capabilities, including English
• EU-CTR submission experience essential
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Ability to handle change and ambiguity
• Ability to work on multiple projects
• Applicants will ideally have knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and GCP/ICH