Clinical Operations Lead

Responsibilities

• Lead Local Study Teams (LSTs) at the country level to deliver clinical studies within budget, timelines, and regulatory guidelines.
• Oversee the entire site lifecycle, including identification, qualification, setup, initiation, monitoring, closure, and documentation archiving.
• Manage and optimize the performance of CRAs and CSAs to ensure compliance with ICH-GCP and client procedural documents.
• Coordinate site selection processes, including performing Site Quality Risk Assessments and conducting Site Qualification Visits.
• Proactively identify study risks and facilitate the resolution of complex clinical and operational issues.
• Manage study documentation, ensuring the completeness and inspection-readiness of the eTMF.
• Oversee regulatory submissions to EC/IRB and coordinate with Regulatory Affairs for authority submissions.
• Manage country-level financial aspects, including study management agreements, site budgets, and accurate payments.

Requirements

• Extensive experience in Clinical Operations, specifically in a Clinical Operations Lead, Clinical Trial Manager, or equivalent role.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials.
• Strong knowledge of international ICH-GCP guidelines and relevant local regulations.
• Bachelor's degree in a life science discipline or a related field.
• Proficiency in written and spoken English.
• Fluency in the local language.
• Excellent project management, organizational, and communication skills.
• Ability to travel nationally and internationally as required.

Preferred Qualifications

• Experience in site monitoring and performing co-monitoring or accompanied site visits.
• Strong analytical, financial management, and resource management skills.
• Knowledge of the drug development process and clinical study monitoring processes.
• Experience with clinical trial management systems (CTMS) and electronic Trial Master Files (eTMF).

Benefits

• Opportunities for professional and personal development and career advancement.
• A supportive culture that prioritizes employee growth and wellness.
• Flexible work arrangements to meet personal needs.

About the Company

Parexel is a global leader in clinical research, dedicated to putting patients at the heart of every clinical trial. With a global footprint and thousands of team members worldwide, we work to bring innovative medical treatments to patients faster through excellence and empathy.