Clinical Operations Lead

About This Opportunity

We are representing a confidential clinical research organization seeking a Clinical Operations Lead based in Poland (home-based). This role provides comprehensive oversight of clinical trial operations at a regional or global level, managing Clinical Research Associates and investigator sites while ensuring full compliance with protocols, GCP, ICH guidelines, and local regulations.

Our talent team at Get A Job.ai is conducting the search for this position. Candidates will apply through our platform, undergo screening with our recruiters, and be submitted to the client for consideration.

Responsibilities

As Clinical Operations Lead, you will:

• Provide overall oversight of regional CRAs to ensure compliance with study protocols, ICH-GCP, local regulations, and study timelines
• Conduct monitoring support visits (co-monitoring) to aid sites and CRAs in achieving satisfactory performance and compliance
• Review visit reports for quality, compliance, and appropriate site management
• Manage site and country performance metrics including recruitment, data collection, document collection, and TMF review
• Oversee regional startup and feasibility activities
• Support vendor management activities as required per project
• Contribute to financial project management processes, potentially including revenue recognition and site payment review
• Conduct regular global and individual CRA calls with monitoring and site management teams
• Attend client meetings to provide status updates on country and site progress
• Provide project-specific training and mentoring to regional CRAs on study procedures, clinical plans, and timelines
• Serve as first point of contact for regional CRAs regarding study-specific questions and issues
• Conduct CRA assessment visits to evaluate performance against monitoring responsibilities
• Develop training materials, study tools, monitoring plans, and enrollment strategies
• Prepare and deliver presentations for kickoff meetings, investigator meetings, and site visits
• May temporarily or permanently manage investigator sites, including CRA responsibilities

What We're Looking For

Required Experience (one of the following):

• College diploma/degree AND 7-9 years of related experience with continuous training and skills development
• Undergraduate university degree (Bachelor's or Honours Bachelor's) AND 4-6 years of experience with substantial ongoing job-related training

Minimum Qualifications:

• Minimum 3 years of CRA experience
• Strong experience with EDC systems
• Proficiency with MS Office
• Strong written and verbal communication skills
• Highly effective interpersonal and organizational skills
• Demonstrated understanding of GCPs and local regulations as they relate to clinical monitoring, IRB/EC, and investigator responsibilities
• Proven ability in report writing and critical analysis of clinical research documents
• Ability to handle multiple tasks and meet deadlines in a dynamic environment

Preferred:

• Health Sciences, Life Sciences, or Nursing specialty background
• SoCRA and/or ACRP Certification/Designation

Personal Attributes:

• Proactive and detail-oriented
• Task-driven and highly organized
• Strong problem-solving capabilities

How We Work With You

Get A Job.ai is managing this search on behalf of our client. Here's our process:

• Submit your application through the Get A Job.ai platform
• Our recruiting team will screen qualified candidates and conduct initial interviews
• We will present shortlisted candidates to our client for consideration
• Please do not contact the client directly; all communication should go through Get A Job.ai

Employment Details

Location: Poland (home-based/remote)

Employment Type: Full-time

Pay: Compensation details will be discussed during the screening process with our recruiting team.

Equal Opportunity

Get A Job.ai is committed to inclusive hiring practices. We welcome applications from all qualified candidates and provide accommodations throughout our recruitment process upon request.