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

Role Summary

Senior Clinical Study Lead with global responsibility for the execution of large and/or complex clinical trials from design through close-out. Accountable for study timelines and budgets, ensuring conduct in accordance with SOPs and ICH/GCP. Requires onsite presence and may involve relocation.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and serves as the primary point of contact for leadership and oversight for the assigned study
• Provides operational input into protocol development
• Oversees development of study documentation including CRFs, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, statistical analysis plan, etc.
• Oversees setup and maintenance of study systems (CTMS, TMF)
• Ensures compliance with clinical trial registry requirements
• Identifies outsourcing needs and leads engagement, contracting, and management of vendors
• Provides input into baseline budget and timeline development and management
• Leads risk assessment and mitigation strategies at the study level
• Leads feasibility assessment to select regions/countries for the study
• Oversees site evaluation and selection; leads investigator meeting preparation and execution
• Monitors site activation and monitoring visits, and addresses deviations from plan
• Leads development and implementation of patient recruitment and retention strategies
• Monitors data entry and query resolution and addresses deviations from metrics
• Ensures accurate budget management and scope changes
• Oversees study drug and clinical supplies forecasting, accountability, and reconciliation
• Escalates issues related to study conduct, quality, timelines or budget and develops corrective actions
• Oversees execution of the study against timelines, deliverables, and budget
• Oversees data quality and regular review of data metrics and protocol deviations
• Ensures CROs and third-party vendors are aligned with the scope of work
• Ensures clinical project audit and inspection readiness
• Supports internal and external audits and contributes to CAPAs
• Manages study close-out activities including database lock, budget reconciliation, TMF, and drug accountability
• Contributes to clinical study report writing and review
• Facilitates study-level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Participates in cross-functional/process-improvement initiatives
• Identifies innovative approaches to clinical study execution and continuous improvement of CTM SOPs
• May be assigned unmasked tasks (e.g., handling unmasked IP, IVRS issues) and supports oversight of unmasked monitoring
• Supervises CTM staff, including performance management, recruitment, development, coaching, and compliance
• May require up to 25% travel

Qualifications

• Required: Bachelor's degree; minimum 8 years of relevant clinical trial experience at sponsor, CRO, or site
• Preferred: Prior experience in Obesity/Metabolism/Diabetes trials; extensive Phase III experience

Skills

• Exceptional interpersonal and leadership skills
• Advanced expertise in operational strategy for clinical studies
• Data-driven planning, execution, and problem-solving
• Advanced communication skills (verbal, written, presentation)
• Proactive, self-disciplined with strong time management and prioritization
• Ability to influence and negotiate with 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 trial management systems and MS Office (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Global clinical trial operations experience and ability to contribute to protocol and key documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Advanced project management and cross-functional leadership
• Line management experience

Education

• Bachelor's degree or higher

Additional Requirements

• On-site work required; relocation provided to qualifying candidates
• Up to 25% travel may be required