Associate Clinical Operations Leader/Reviewer

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking Associate Clinical Operations Leaders to join our team. In this role, you will review clinical site visit reports, identify and analyze trends and issues, and communicate meaningful insights to Clinical Operations Leaders. Through the collaboration and diversity of our teams, the Associate Clinical Operations Leader is provided with multiple opportunities to excel and discover where your skills can take you, including a natural career path toward a Clinical Operations Leader role.

Who we’re looking for:

An experienced clinical research professional who brings strong quality focus, analytical thinking, clear communication, sound judgment, and the ability to work collaboratively across virtual teams. You are proactive in identifying issues, comfortable prioritizing competing needs, and able to build trust with internal and external stakeholders.

What you’ll do:

• Review site qualification, initiation, monitoring and close-out visit reports for quality, completeness, SOP, ICH-GCP and protocol compliance.
• Capture report information in dashboards and analyze issues, categories, issue age and recurring trends for the Clinical Operations Leader team.
• Identify potential data quality or compliance concerns, assess impact on study timelines, and escalate critical issues with recommended solutions.
• Communicate study-specific trends and issues to Clinical Operations Leaders and support regular trend reporting.
• Escalate identified CRA report-quality or documentation concerns through the appropriate line-management channels.

Experience and qualifications:

• Strong command of written and spoken English and Spanish required.
• Minimum of five years of Senior CRA experience is required. Relevant Clinical Operations Leader or project-lead experience will also be considered.
• Strong understanding of the clinical trial process, cross-functional clinical activities, site management, data processing and data cleaning.
• Degree in a life science, nursing qualification, or relevant clinical and/or clinical management experience.

Additional details:

• This position can be fully home based in Mexico or Colombia.
• Very occasional travel for monitoring support may be required
• The role works under the guidance of an experienced Clinical Operations Leader or Line Manager and may have sponsor-facing responsibilities.

Why join us:

• Be part of groundbreaking projects that are pushing the boundaries of the industry.
• Experience a collaborative and inclusive work environment that highly appreciates your expertise.
• Unlock your full potential with professional growth and development opportunities.
• Enjoy work life balance and flexible working hours.

This is an excellent opportunity for experienced Senior CRAs looking to reduce routine site travel and expand into broader clinical operations leadership. This role provides experience with selected Clinical Operations Leader activities and a clear progression toward a Clinical Operations Leader role.

At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you’re exposed to a world of experiences and open doors.

If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!

Originally posted on Himalayas