Regulatory and Start Up Specialist - Poland

IQVIA LLC; Warszawa; Teletrabalho; PLN 151 000 - 281 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Home-based in Poland

Global clinical studies exposure

Career development opportunities

Resumo da oferta

IQVIA LLC is seeking an RSU Specialist Level: Senior Associate for a home-based role in Poland. You will act as the key contact for investigative sites, Site Activation Managers, and project teams to ensure compliant site activation activities.

Responsibilities include managing regulatory submissions, contract negotiations, and documentation control, while coordinating with sponsors and cross-functional teams to start up studies efficiently.

Qualificações

• Bachelor’s degree in Life Sciences or related field.
• 3.5–5 years of clinical research experience.
• Strong experience in Site Activation, regulatory submissions, CTAs, and contract negotiations.
• Solid understanding of Italian and international clinical trial regulations.
• Fluency in Polish and strong English communication.
• Excellent planning and stakeholder management skills.

Responsabilidades

• Serve as primary contact for investigative sites and internal stakeholders.
• Coordinate and execute country-specific site activation and regulatory activities.
• Prepare, review, and distribute regulatory documentation for completeness and compliance.
• Track submissions, approvals and execution of essential documents (ICFs, CTAs, IP release).
• Support contract negotiation activities and timelines.
• Maintain accurate records in internal systems and monitor project milestones.

Conhecimentos

Site Activation

Regulatory Submissions

CTAs

Start-up Activities

Regulatory Knowledge

Stakeholder Management

Formação académica

Bachelor’s Degree in Life Sciences

Descrição da oferta de emprego

RSU Specialist Level: Senior Associate Location: Poland (Home Based)

About IQVIA

IQVIA is a leading global provider of clinical research services, healthcare intelligence, and commercial insights to the life sciences industry. With more than 88,000 employees worldwide, we help accelerate the development and commercialization of innovative treatments that improve patient outcomes and population health. As a global leader in clinical development, we combine data, technology, scientific expertise, and operational excellence to help our customers navigate the complex healthcare landscape and bring new therapies to patients faster.

The Opportunity

We are seeking an experienced RSU Specialist to join our FSP team in Poland. This home-based position requires strong knowledge of local regulatory requirements, site activation processes, and contract negotiations. Fluency in Polish is essential. In this role, you will act as the key point of contact for investigative sites, Site Activation Managers (SAMs), project teams, and other stakeholders, ensuring site activation activities are completed efficiently and in compliance with local regulations, SOPs, and project timelines.

Key Responsibilities

• Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers, and internal stakeholders.
• Coordinate and execute country-specific site activation and regulatory activities.
• Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.
• Track and manage submission, approval, and execution of essential documents, including regulatory submissions, Ethics Committee submissions, Informed Consent Forms (ICFs), Investigator Pack (IP) release documentation, Clinical Trial Agreements (CTAs).
• Support contract negotiation activities and timelines.
• Maintain accurate records within internal systems and tracking tools.
• Monitor project milestones and proactively identify risks and mitigation plans.
• Provide local regulatory expertise to project teams and Site Activation Managers.
• Perform quality reviews of site documentation.
• Review site performance metrics and contribute to continuous process improvement initiatives.
• Collaborate closely with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery.

What We're Looking For

• Bachelor’s Degree in Life Sciences or a related scientific discipline.
• Approximately 3.5 to 5 years' experience within clinical research.
• Strong experience in: Site Activation, Regulatory submissions, Clinical Trial Agreements (CTAs) and contract negotiations, Clinical trial start-up activities, Solid understanding of Italian and international clinical trial regulations.
• Fluency in Polsih with strong English communication skills.
• Excellent planning, organization, and problem-solving abilities.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Strong stakeholder management and communication skills.

Why Join IQVIA?

Home-based flexibility within Poland.

Opportunity to work on innovative and impactful clinical studies.

Exposure to a wide range of therapeutic areas and sponsors.

Global career development and advancement opportunities.

Collaborative and inclusive culture focused on growth and continuous learning.

Join a team dedicated to accelerating healthcare innovation and improving patient outcomes worldwide.

Additional Information

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.

We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł151 200,00 - zł280 700,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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.

Learn more at https://jobs.iqvia.com

Thank you for your interest in growing your career with us.