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, perform Site Quality Risk Assessments, and conduct Site Qualification Visits.
• Proactively identify study risks and facilitate the resolution of complex clinical and operational issues.
• Manage country-level documentation, ensuring the completeness and inspection-readiness of the eTMF.
• Oversee regulatory submissions and ensure timely communication with EC/IRB and local regulatory authorities.
• Manage study budgets, including the preparation of financial agreements and ensuring accurate site 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.

Preferred Qualifications

• Experience in site monitoring or performing co-monitoring/accompanied site visits.
• Knowledge of the drug development process and clinical study monitoring processes.
• Experience with Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF).
• Strong financial management and negotiation skills.

Benefits

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

About the Company

Parexel is a global leader in clinical research, dedicated to helping innovative treatments reach patients faster. With a massive global footprint and a mission-driven culture, we combine expertise and empathy to optimize clinical trials and advance medical possibilities.