[Hiring] Clinical Associate Submissions – Regulatory @IQVIA

Role Description

Position requires EU CTR experience for Germany and Austria, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. 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. May also include maintenance activities.

As Regulatory & Start-Up Specialist, you will:

• Work and lead complex projects under general supervision.
• Serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.
• Prepare submission documents and submit to regulatory bodies.
• 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 and review for completeness and accuracy.
• Review, track, and follow up the progress, approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.
• Inform team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites.
• Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• Act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.

Qualifications

• B Sc degree in Health Sciences or related field.
• 1 - 3 years' relevant clinical research experience, specifically in submissions.
• Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for DACH regions.
• Experience in Site Contract negotiations with DACH sites.
• Experience in medical device submissions is beneficial.
• In-depth knowledge of clinical systems, procedures, and corporate standards.

Requirements

• Good negotiating and communication skills in local language.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Understanding of regulated clinical trial environment and knowledge of drug development process.

Company Description

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.