[Hiring] Regulatory and Start-Up Specialist 1 @IQVIA

Role Description

The Regulatory and Start-Up Specialist 1 is responsible for supporting the site identification process and performing regulatory start-up and maintenance activities in accordance with regulations, SOPs, and project requirements at the global, regional, or country level. This role involves:

• Preparing and managing site regulatory documentation.
• Reviewing and negotiating site regulatory documents and contracts with sites and sponsors.
• Maintaining, reviewing, and reporting on site performance metrics.
• Serving as the primary point of contact for investigative sites.
• Tracking completion of regulatory and contractual documents for sites.
• Ensuring contracts are fully executed.
• Establishing project timelines.

Additionally, the role includes performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, SOPs, project requirements, and contractual/budgetary guidelines.

• 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 SOPs, Work Instructions (WIs), quality of designated deliverables, and project timelines.
• Perform 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 regulatory 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 plans as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track, and follow up on the progress, approval, and execution of documents, 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 ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• High School Diploma or equivalent.
• Previous experience in regulatory and start-up activities.
• Knowledge of applicable regulations and compliance requirements.
• German language fluency.

Company Description

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Our work accelerates the development and commercialization of medical treatments that improve patient outcomes and population health worldwide. IQVIA’s global team of 88,000+ professionals spans more than 100 countries supporting clinical research at every scale.

As the world’s largest clinical trial site network and CRA footprint, we empower our clinical teams to work confidently, collaboratively, and globally.