Senior Clinical Study Lead

Primary Responsibilities

• Lead cross-functional study teams and act as the primary point of contact for study delivery and oversight
• Drive global clinical trial execution, ensuring adherence to timelines, budgets, and quality standards
• Oversee development of key study documentation (e.g., CRFs, data management plans, monitoring plans, SAPs)
• Manage and maintain clinical trial systems such as CTMS and TMF
• Identify outsourcing needs and oversee vendor selection, contracting, and performance management
• Contribute to budget planning and timeline development across the study lifecycle
• Conduct risk assessments and implement mitigation strategies
• Lead feasibility assessments and support country/site selection
• Monitor study progress including site activation, recruitment, data quality, and metrics performance
• Oversee clinical supply planning, drug accountability, and reconciliation
• Escalate study risks and issues, ensuring timely resolution and stakeholder alignment
• Lead study close-out activities including database lock, vendor reconciliation, and TMF completion
• Support unblinded study activities where applicable
• Provide line management, coaching, and development for Clinical Trial Management staff

Skills & Requirements

• Bachelor’s degree (or higher) in a relevant scientific discipline
• Extensive experience in global clinical trial operations, including large and/or complex studies
• Proven leadership and line management experience
• Strong knowledge of ICH-GCP and regulatory requirements
• Demonstrated ability to manage budgets, timelines, and vendors
• Advanced proficiency in clinical systems (e.g., CTMS, EDC, IVRS/IWRS) and MS Office tools
• Strong stakeholder management, communication, and negotiation skills
• Ability to operate independently, prioritize effectively, and manage competing deadlines
• Experience in protocol development, risk management, and patient recruitment strategies

Compensation

$80.00 - $95.00 Per Hour