Global Clinical Operations Leader / Clinical Trial Manager

Key Responsibilities

• Lead global clinical operations strategy and execution for assigned clinical trials.
• Drive study startup including site selection, monitoring strategy, and operational planning.
• Cook up cross functional teams across geographies ensuring alignment on timelines, quality, and deliverables.
• Monitor study progress including recruitment, retention, data quality, and timelines and take corrective action when needed.
• Identify risks early and implement mitigation and contingency plans.
• Provide leadership direction and performance feedback to project team members.
• Serve as the primary point of contact for sponsors on clinical operations topics.
• Ensure compliance with ICH GCP regulatory requirements and internal processes.
• Oversee maintenance and quality of study documentation and central files.
• Support audits, inspections, and study closeout activities including database lock and archiving.
• Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture.

Required Qualifications

• Degree in life sciences, nursing, or equivalent clinical research experience.
• Minimum of 5 years of experience leading clinical operations within a CRO environment.
• Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader.
• Strong knowledge of ICH GCP regulatory requirements and clinical trial processes.
• Experience leading complex global or multi-region studies.
• Experience coordinating cross functional teams and managing study timelines, budgets, and quality.
• Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF.

Preferred Qualifications

• Prior monitoring experience or strong site engagement background.
• Experience contributing to process improvements or operational excellence initiatives.
• Familiarity with multiple therapeutic areas or late phase studies with priority given to those with Metabolic, Obesity, MASH, Ophthalmology and Dermatology / Immunology.