Clinical Operations Lead (Clinical Trial Manager)

Role Overview

The Clinical Operations Lead holds overall responsibility for clinical operations within a specified regional or global project scope. This role oversees clinical activities and deliverables, supervises Clinical Research Associates (CRAs) and Investigator sites, and ensures adherence to protocols, Good Clinical Practice (GCP), ICH guidelines, and local regulations. The Lead acts as a key liaison between CRAs and the clinical project team while managing training, monitoring strategies, and documentation.

Key Responsibilities

• Provide comprehensive oversight of regional CRAs to guarantee compliance with study protocols, timelines, and regulatory standards.
• Conduct support and co-monitoring visits to ensure sites and CRAs perform satisfactorily and follow compliance requirements.
• Coordinate activities related to startup, feasibility, and vendor management aligned with project needs.
• Review visit reports to ensure quality, protocol adherence, and effective site management.
• Monitor site and country performance metrics including recruitment, data and document collection, and TMF reviews, informing the clinical project team of progress.
• Contribute to financial management activities, such as revenue tracking and site payment review.
• Occasionally assume CRA duties or oversee investigator sites if required.
• Maintain communication through global and regional CRA calls and meetings with study sponsors to provide progress updates.
• Offer operational guidance and mentoring to CRAs, ensuring all training requirements are fulfilled and recorded.
• Serve as the first point of contact for CRAs regarding study-related queries and escalate issues appropriately.
• Facilitate CRA assessments to evaluate monitoring performance and support line managers concerning CRA utilization and performance reports.
• Develop and implement study tools, monitoring plans, and participant recruitment/enrollment strategies, and prepare presentation materials for key study meetings.

Qualifications and Experience

• Either college diploma/degree with 7-9 years of related experience plus continuous professional development, or an undergraduate university degree (bachelor's or honors) combined with 4-6 years of relevant experience and extensive job-related training.
• Preferred background in Health Sciences, Life Sciences, or Nursing, or possession of SoCRA and/or ACRP certification/designation.
• Minimum of 3 years’ experience as a Clinical Research Associate, with strong knowledge of electronic data capture (EDC) systems and proficiency in Microsoft Office.
• Exceptional written and verbal communication, interpersonal abilities, and organizational skills.
• Attributes include being proactive, detail-oriented, task-focused, and highly organized.
• Solid understanding of GCP principles, local regulations, IRB/EC procedures, and investigator responsibilities pertinent to clinical monitoring.
• Skilled in report writing and critical review of clinical research documents.
• Adept at managing multiple assignments and meeting deadlines in a dynamic work environment.

Working Conditions

This position is home-based.

Additional Information

Accommodations for individuals with disabilities are available upon request throughout the recruitment and selection process; such requests can be sent via email.

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Use of Artificial Intelligence: AI tools may assist in application and hiring processes by analyzing resumes and responses; however, all final hiring decisions are made by human personnel.