Manager, Study Start Up, IQVIA Biotech
Department: IQVIA Biotech
Location: Serbia (Hybrid/Office-based depending on business needs)
Job Overview
The Manager, Study Start Up is responsible for leading and managing site activation activities within assigned clinical research projects. This role provides people leadership, operational oversight, and quality management to ensure study startâup activities are executed in compliance with applicable regulations, ICH/GCP guidelines, and IQVIA Biotech policies. The role also contributes to process improvements and resource planning to support efficient and highâquality study delivery.
Essential Functions
People Leadership & Talent Management
- Manage staff delivery of site activation activities in accordance with organizational policies, SOPs, and applicable regulatory requirements.
- Provide direct people leadership, including planning, assigning, and directing work; assessing performance; coaching and supporting professional development.
- Recognize and reward strong performance, address performance issues, and proactively manage employee relations matters.
- Participate in the hiring process by reviewing candidates and conducting interviews to ensure selection of qualified talent.
- Ensure new hires are effectively onboarded and receive appropriate training to succeed in their roles.
Training, Development & Compliance
- Ensure staff have the required tools, systems access, and training to perform their responsibilities effectively.
- Provide oversight for execution of training plans, including SOP review and required training experiences.
- Maintain a strong focus on compliance with ICH/GCP guidelines and applicable global and local regulatory requirements.
- Serve as a role model for quality, compliance, and ethical conduct.
Resource Planning & Operational Oversight
- Participate, as required, in resource allocation activities by assigning staff to projects based on experience, competency, and training.
- Monitor workload distribution to ensure capacity, efficiency, and delivery against timelines.
- Apply effective management practices such as work scheduling, prioritization, coaching, and execution discipline.
Quality Management & Performance Monitoring
- Manage the quality of assigned staffâs work through regular review and evaluation of deliverables.
- Identify quality risks, issues, or performance gaps and develop corrective and preventive action plans (CAPAs) to address deficiencies.
- Ensure staff meet defined workload, productivity, and quality metrics through regular reporting and review, in alignment with clinical operations management expectations.
Process Improvement & Problem Solving
- Lead and support moderate-scale improvements to processes, systems, or tools to enhance operational effectiveness and quality.
- Address complex operational challenges that require understanding of broader business, project, or regulatory considerations.
- Collaborate crossâfunctionally to drive consistency, continuous improvement, and best practices within Study Start Up.
Qualifications & Experience
- Strong knowledge of clinical research processes, with demonstrated experience in study startâup and site activation activities.
- Good working knowledge and practical application of ICH/GCP and applicable regulatory guidelines.
- Proven people management experience, including coaching, performance management, and employee development.
- Ability to manage complexity, prioritize competing demands, and make sound operational decisions.
- Strong communication, leadership, and stakeholder management skills.
- University degree in Life Sciences or a related field (or equivalent experience).
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.