Regulatory & Start-Up Specialist (Spec 2)

About the role

iQVIA is looking for a Regulatory & Start-Up Specialist (Spec 2) in Warsaw. You will perform country-level tasks linked to site activation (SA) activities in clinical studies, following local and international regulations, standard operating procedures (SOPs), project requirements and budgetary guidelines. Maintenance activities may also be included.

Key responsibilities

• Serve as Single Point of Contact (SPOC) for assigned studies with investigative sites, the Site Activation Manager, the project management team and other departments, ensuring adherence to SOPs, work instructions, deliverable quality and timelines.
• Carry out start-up and site activation activities and distribute completed documents to sites and the project team.
• Prepare site regulatory documents and review them for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project-specific information.
• Review and give feedback to management on site performance metrics, and review, set and agree project planning and timelines, including contingency plans.
• Track and follow up the approval and execution of regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
• Provide local expertise to Site Activation Managers and the project team during planning, and perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Required profile

• Bachelor's degree in life sciences or a related field and 3 years of clinical research or other relevant experience; or an equivalent combination of education, training and experience.
• 3 years of clinical research experience, including 1 year in a leadership capacity, or an equivalent combination.
• Understanding of the regulated clinical trial environment and the drug development process.

Required skills

• In-depth knowledge of clinical systems, procedures and corporate standards.
• Knowledge of GCP/ICH and applicable regulatory guidelines, including local regulations, SOPs and company standards.
• Good negotiating and communication skills, with the ability to challenge where applicable.
• Ability to work independently, prioritize tasks, manage multiple projects and build effective working relationships.

The potential base pay range, annualized, is PLN 151,200 to PLN 280,700, depending on qualifications, location and schedule. Incentive plans, bonuses and other benefits may also apply.