Maintenance Lead

Study Maintenance Lead

Serbia/Bulgaria/Ukraine/Spain/Portugal/Greece

Job Overview

The Maintenance Lead is responsible for leading the strategic, operational, and financial delivery of clinical study maintenance activities, ensuring the timely implementation of revised clinical study documents, regulatory submissions, approvals, and associated site maintenance activities. This role provides project leadership, stakeholder management, and regulatory oversight to ensure studies remain compliant, on schedule, and aligned with sponsor and company requirements.

Key Responsibilities

• Lead the execution of lifecycle maintenance activities for assigned clinical studies, ensuring compliance with ICH-GCP, regulatory requirements, sponsor expectations, and company policies.
• Develop and implement maintenance strategies, plans, timelines, and deliverables to support efficient study execution.
• Provide project oversight for amendments, regulatory submissions, ethics approvals, essential document updates, and site contract modifications.
• Collaborate with internal and external stakeholders to resolve issues, manage risks, and ensure successful delivery of study objectives.
• Review regulatory requirements and provide strategic guidance on submissions, approvals, and maintenance activities across regions.
• Maintain accurate project documentation, tracking systems, reports, and study records.
• Support business development activities, including bid defenses, proposal development, and transitioned studies.
• Build and maintain strong client relationships, providing regular updates and contributing to customer-focused initiatives.
• Mentor and coach team members, supporting capability development and knowledge sharing.
• Drive continuous improvement initiatives that enhance operational efficiency and study delivery.
  
  

Qualifications & Experience

• Bachelor’s degree in Life Sciences or a related field.
• Minimum 5 years’ experience in a clinical research, regulatory, or scientific environment.
• At least 2 years of leadership or project lead experience.
• Related financial exprience required.
• Demonstrated experience working in a global or international environment.
• Strong knowledge of clinical trial regulations, study maintenance processes, and project management principles.
• Excellent communication, stakeholder management, and problem-solving skills.
  
  

Experience Level: Mid-Senior Level

Function: Clinical Operations / Study Maintenance / Regulatory Affairs

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.