Lead Clinical Research Associate

Accountabilities:

• Lead and oversee clinical trial monitoring activities across assigned studies, ensuring adherence to timelines, enrollment targets, data quality standards, and regulatory compliance while implementing corrective and preventive actions when needed.

• Serve as a primary communication hub between monitors, site management teams, regional leads, and project managers, ensuring smooth coordination and issue resolution.

• Review monitoring visit reports and ensure consistency, completeness, and compliance across all monitoring activities within the region.

• Provide project-level training, develop training materials, and mentor monitors and junior team members, including newly promoted Lead CRAs.

• Supervise data integrity processes, including source data verification, query resolution, and risk identification at site and regional levels.

• Oversee investigational product handling, clinical supplies management, and reconciliation of essential study documents, including ISF/TMF compliance.

• Support study startup activities, feasibility assessments, site selection, audit preparation, CAPA development, and ongoing quality oversight of clinical trial processes.

• Coordinate safety reporting, protocol deviation management, vendor interactions, and ensure timely updates across study tracking systems.

Requirements:

• Degree in Life Sciences or a related field (MD, MPharm, RN, or equivalent combination of education and experience).

• Minimum of 4 years of clinical site monitoring experience, including participation in global clinical trials in a Lead CRA or equivalent role.

• Strong experience in Phase II and/or Phase III clinical trials with full understanding of all monitoring visit types.

• Preferred experience in Oncology, particularly in areas such as Radiation Therapy, Radiopharmaceuticals, CAR-T, Gene Therapy, or Nuclear Medicine.

• Additional therapeutic experience in gastrointestinal conditions (e.g., Crohn’s disease, ulcerative colitis, IBS) is highly valued.

• Strong understanding of clinical trial operations, regulatory requirements, and data integrity standards.

• Excellent communication, leadership, and problem-solving skills with the ability to mentor and coordinate cross-functional teams.

• Proficiency in MS Office and ability to manage multiple priorities in a dynamic, fast-paced environment.

• Willingness and ability to travel as required, with strong organizational and planning capabilities.

Benefits:

• Opportunity to work in a stable yet innovation-driven clinical research organization with a strong international presence.

• Leadership role with high visibility and impact across global clinical trial operations.

• Low-travel model with emphasis on remote oversight and work-life balance.

• Professional growth opportunities through mentorship responsibilities and leadership development.

• Exposure to advanced therapeutic areas such as oncology, gene therapy, and cell therapy.

• Collaborative and people-focused working culture with strong emphasis on quality and compliance.

• Competitive compensation package aligned with experience and responsibilities.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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