Remote Regulatory & Start-Up Specialist (Poland)

IQVIA LLC; Warszawa; Remote; PLN 151,000 - 281,000; Full time

Benefits offered by this job

Home-based in Poland

Global clinical studies exposure

Career development opportunities

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Site Activation

Regulatory Submissions

CTAs

Start-up Activities

Regulatory Knowledge

Stakeholder Management

Education

Bachelor’s Degree in Life Sciences

Job description

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.