Senior Manager Clinical Study Lead (Hematology)

Role Summary

The Senior Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design through study close-out, ensuring timelines, budget, and adherence to SOPs and ICH/GCP. This onsite role oversees studies whether internally managed or CRO-out sourced and drives process improvements.

Responsibilities

• Lead the cross-functional study team and serve as the primary leadership contact for the assigned study
• Provide operational input into protocol development
• Develop and input study-specific documents (CRFs, data management plan, monitoring plan, training plan, data review plan, statistical analysis plan, etc.)
• Set up and maintain study systems (CTMS, TMF, etc.) and ensure registry compliance
• Identify outsourcing needs and oversee vendor engagement, contracting, and management
• Contribute to baseline budget and timeline development and management
• Lead risk assessment and mitigation at the study level
• Lead feasibility assessment to select regions/countries; oversee site evaluation and selection
• Lead investigator meeting preparation and execution
• Monitor site activation, monitoring visits, and deviations; manage patient recruitment and retention strategies
• Monitor data entry and query resolution; ensure adherence to metrics
• Ensure budget accuracy and manage scope changes; oversee drug and supply forecasting and reconciliation
• Escalate issues to Program Operations Leader and implement corrective actions
• Oversee study execution against timelines, deliverables, and budget
• Review data quality metrics, protocol deviations, and non-compliance; ensure alignment with CROs/Third Party Vendors
• Maintain audit/inspection readiness; support internal/external audits and CAPAs
• Manage study close-out activities (database lock, vendor reconciliation, TMF, budget, drug accountability)
• Contribute to clinical study report writing and study-level lessons learned
• Assign tasks to Clinical Study Management staff; support their deliverables
• Participate in cross-functional/process improvement initiatives; identify innovative CTM approaches
• Possibly perform unmasked tasks as assigned (product handling, IVRS issues, unmasked monitoring)
• Direct supervision of CTM staff including performance management, recruitment, development, coaching, and compliance
• May require travel up to 25%

Qualifications

• Required: Bachelors‚Äô degree with minimum 8 years of relevant clinical trial experience
• Preferred: Exceptional interpersonal and leadership skills; strong budget management; extensive global clinical trial operations experience; advanced project management and cross-functional leadership; knowledge of ICH/GCP and regulatory guidelines

Skills

• Operational strategic direction and guidance for clinical studies
• Data-driven planning, execution, and problem solving
• Advanced communication (verbal, written, presentation)
• Vendor management and negotiation
• Technical proficiency in trial management systems and MS Office applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Ability to lead and develop study teams and collaborations

Education

• Bachelors‚Äô degree (required)

Additional Requirements

• Onsite position in an office location; fully remote is not eligible
• May require up to 25% travel