Clinical Start-Up Associate II – Remote/Spain

KCR Placement; Warszawa; Hybrid; PLN 168,000 - 273,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Life insurance

Employee assistance program

Annual leave

Job summary

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines to patients faster. As a Study Start Up Associate II, you will lead site start-up and activation, ensuring regulatory compliance and contributing to innovative therapies.

You will coordinate regulatory submissions, liaise with stakeholders, and maintain accurate records while guiding study teams on regulatory best practices. Travel around 5% may be required.

Qualifications

• Bachelor's degree in life sciences or a related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with study start-up exposure.
• Strong understanding of regulatory requirements and guidelines (ICH-GCP and local regulations).
• Fluency in English and at least one local language (Italian, Dutch or Nordics).
• Excellent organizational and project management skills with ability to multitask.
• Willingness to travel about 5%.

Responsibilities

• Lead the preparation and submission of regulatory documents (clinical trial applications, ethics submissions, regulatory communications).
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive records of submissions, approvals, and correspondence.
• Provide guidance on regulatory requirements and best practices for study start-up.
• Participate in process improvement initiatives to streamline start-up processes.

Skills

Regulatory knowledge

Project management

Communication

Interpersonal skills

Travel willingness

Education

Bachelor's degree in life sciences or related field

Job description

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines to patients faster. As a Study Start Up Associate II, you will lead site start-up and activation, ensuring regulatory compliance and contributing to innovative therapies.

You will coordinate regulatory submissions, liaise with stakeholders, and maintain accurate records while guiding study teams on regulatory best practices. Travel around 5% may be required.