Senior Manager Clinical Study Lead (Diabetes/Obesity/Metabolism)

Role Summary

Senior Clinical Study Lead (Diabetes/Obesity/Metabolism) is accountable for the global execution of assigned large and/or complex clinical trials from study design through to study close out, ensuring study timelines and budgets, and adherence to SOPs and ICH/GCP. May oversee internally sponsored studies or studies outsourced to CROs, with varying levels of direct leadership.

Responsibilities

• Leads the cross-functional study team and serves as the primary point of contact for leadership and oversight for the assigned study
• Provides operational input into protocol development
• Develops and maintains study documentation (CRFs, data management plan, monitoring plan, training plan, data review plan, statistical analysis plan, etc.)
• Sets up and maintains study systems (CTMS, TMF, etc.) and ensures compliance with registry requirements
• Identifies outsourcing needs, leads vendor engagement, contracting, and management
• Contributes to baseline budget and timeline development and management
• Leads risk assessment and mitigation strategies at the study level
• Leads feasibility assessments to select regions/countries and oversees site evaluation/selection
• Leads investigator meeting preparation and execution
• Monitors site activation, monitoring visits, and deviations from plan
• Develops and implements patient recruitment and retention strategies, and monitors deviations
• Monitors data entry and query resolution, acting on deviations
• Ensures budget accuracy and scope changes for internal and external studies
• Oversees study drug and clinical supplies forecasting, accountability, and reconciliation
• Escalates issues to Program Operations Leader and implements corrective actions
• Oversees execution against timelines, deliverables, and budget
• Monitors data quality and regulatory compliance at sites
• Ensures CROs/Third Party Vendors align with scope of work
• Ensures audit/inspection readiness throughout the study lifecycle
• Supports internal/external audits and CAPAs as needed
• Manages study close-out activities (database lock, vendor contracts, budget, TMF, drug accountability)
• Contributes to clinical study report writing and study-level lessons learned
• Assigns tasks to Clinical Study Management staff and supports deliverables
• Participates in cross-functional process improvement initiatives
• Identifies innovative approaches to study execution and continuous CTM SOP improvement
• May perform unmasked tasks related to unmasked trial activities as needed
• Supervises CTM staff with performance management, recruitment, development, coaching, and compliance
• May require up to 25% travel

Qualifications

• Minimum of Bachelor's degree required
• 8+ years of relevant clinical trial experience at sponsor, CRO, or site
• Prior experience in Obesity/Metabolism/Diabetes related trials
• Extensive Phase III experience

Skills

• Exceptional interpersonal and leadership skills
• Operational strategy and guidance for clinical studies
• Data-driven planning, execution, and problem solving
• Advanced communication (verbal, written, presentation)
• Proactive, self-disciplined, deadline-oriented, time management, prioritization
• Influence and negotiation across stakeholders
• Strong budget management experience
• Industry trend awareness
• Ability to build and develop study teams
• Vendor management with advanced negotiation and interpersonal skills
• Technical proficiency in CTMS, EDC, IVRS/IWRS, MS Office
• Extensive global trial operations experience
• Knowledge of ICH/GCP and regulatory guidelines
• Advanced project management and cross-functional leadership
• Line management experience

Education

• Bachelor's degree required