Clinical Trial Manager
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ā¢ Lead the cross-functional Clinical Management Team for assigned trials, including oversight and coordination of CRO partners.
ā¢ Drive the operational execution of clinical studies against agreed timelines, budgets, quality expectations, and study objectives.
ā¢ Coordinate internal and external stakeholders to maintain alignment, resolve operational challenges, and ensure continued trial progress.
ā¢ Support CRO selection, define scopes of work, and oversee CRO performance throughout study delivery.
ā¢ Identify study issues and ensure appropriate and timely escalation when trial progress, quality, patient safety, or data integrity may be affected.
ā¢ Lead proactive trial risk identification, assessment, mitigation, and follow-up, with particular attention to patient safety and data integrity.
ā¢ Maintain oversight of study finances, including budget updates, forecasting, accruals, invoice review, and ongoing cost monitoring.
ā¢ Participate in audits and regulatory inspections and coordinate timely responses and follow-up activities when required.
ā¢ Ensure clinical trial activities and documentation meet relevant regulatory requirements, internal SOPs, and ICH-GCP standards. Requirements
ā¢ Bachelor's or Master's degree in a relevant scientific, life sciences, or related discipline; a Master's degree is preferred.
ā¢ At least 5 years of professional experience in Clinical Operations.
ā¢ Demonstrated experience independently leading and managing clinical trials.
ā¢ Strong experience coordinating clinical study activities across multiple functions and stakeholders.
ā¢ Practical experience managing and overseeing CROs or other external clinical-service providers.
ā¢ Experience maintaining and overseeing essential clinical trial documentation.
ā¢ Proven exposure to clinical trial budget monitoring and financial management.
ā¢ Strong understanding of clinical trial quality, compliance, risk management, and ICH-GCP requirements.
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