Global Clinical Operations Lead

Alimentiv 2; Warszawa; On-site; PLN 453,858 - 680,787; Full time

Job summary

Alimentiv 2 is seeking a Senior Clinical Operations Lead to oversee regional CRAs and Investigator sites within a defined global framework. You will ensure adherence to protocol, GCP, ICH guidelines and regulatory requirements, while coordinating with the clinical project team.

This home-based role involves developing study tools, training CRAs, monitoring visits, and driving enrollment strategies to deliver timely results across multiple countries.

Qualifications

• 7–9 years related experience with continuous training and knowledge/skills upgrading.
• Undergraduate degree (Bachelors or Honors) with 4–6 years of experience and ongoing training.
• Health Sciences, Life Sciences or Nursing background preferred; SoCRA/ACRP certification desirable.

Responsibilities

• Oversee regional CRAs to ensure site compliance with protocol, ICH-GCP and local regulations.
• Support monitoring visits to ensure quality and compliance.
• Provide oversight of study deliverables across departments (Data Management, TMF Operations).
• Oversee regional startup and feasibility activities.
• Assist in vendor management as required per project.
• Review visit reports for quality and compliance.
• Ensure timely project deliverables per monitoring plan.
• Manage site and country performance metrics including recruitment and data collection.

Skills

Communication skills

Interpersonal skills

Organizational skills

Proactive

Detail oriented

Multitasking

Education

Health Sciences / Life Sciences background

Bachelor's degree

SoCRA/ACRP Certification

Tools

EDC systems

MS Office

Job description

Alimentiv 2 is seeking a Senior Clinical Operations Lead to oversee regional CRAs and Investigator sites within a defined global framework. You will ensure adherence to protocol, GCP, ICH guidelines and regulatory requirements, while coordinating with the clinical project team.

This home-based role involves developing study tools, training CRAs, monitoring visits, and driving enrollment strategies to deliver timely results across multiple countries.