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

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 execution to study close-out, operating with a high degree of independence. The role oversees study timelines and budgets and ensures conduct in accordance with SOPs and ICH/GCP, whether studies are internal or outsourced to CROs, with varying levels of direct leadership versus oversight. On-site, relocation is provided for qualified candidates.

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 and contributes to the development of study documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, statistical analysis plan)
• Oversees setup and maintenance of study systems (CTMS, TMF, etc.)
• Ensures compliance with clinical trial registry requirements
• Identifies outsourcing needs and leads engagement, contracting, and management of required vendors
• Provides input into baseline budget and timeline development and management
• Leads risk assessment and mitigation strategies at the study level
• Leads feasibility assessments to select regions/countries for the study
• Oversees site evaluation/selection and investigator meeting preparation/execution
• Monitors site activation, monitoring visits, and deviations from plan
• Leads the development and implementation of patient recruitment and retention strategies
• Monitors data entry and query resolution and acts on deviations from metrics
• Ensures accurate budget management and scope changes for internal and external studies
• Oversees drug and clinical supplies forecasting, accountability, and reconciliation
• Escalates issues related to study conduct, quality, timelines, or budget and develops appropriate actions
• Oversees execution of the clinical study against planned timelines and budget
• Oversees data quality, including metrics, protocol deviations, eligibility violations, dosing deviations, and suspected non-compliance
• Ensures CROs and third-party vendors align with the scope of work
• Ensures clinical project audit and inspection readiness throughout the study lifecycle; supports internal audits and external inspections and contributes to CAPAs
• Manages study close-out activities (database lock, vendor contracts reconciliation, budget, TMF, drug accountability)
• Contributes to clinical study report writing/review and study-level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Supports cross-functional/process improvement initiatives; identifies innovative approaches to study execution and CTM SOP improvements
• May perform unmasked tasks related to studies (e.g., IVRS issues, unmasked TMF management, unmasked data review) as assigned
• Directly supervises CTM staff, including performance management, recruitment, development, and compliance
• May travel up to 25%

Qualifications

• Required: Bachelor's degree and a minimum of 8 years of relevant clinical trial experience (sponsor, CRO, or site)
• Prior experience in Obesity/Metabolism/Diabetes-related trials
• Extensive Phase III experience
• Exceptional interpersonal and leadership skills; ability to lead cross-functional teams
• Advanced expertise in operational strategy for clinical studies; data-driven planning, execution, and problem solving
• Strong budget management experience and ability to manage timelines and resources
• Advanced communication skills (verbal, written, presentation) and ability to influence across stakeholders
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Advanced project management, cross-functional leadership, and organizational skills
• Line management experience

• Preferred: Ability to build and develop productive study teams; advanced negotiation and vendor management skills
• Advanced technical proficiency in trial management systems and MS Office (Projects, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Awareness of relevant industry trends; ability to identify innovative approaches to clinical study execution
• Experience with protocol development, key study documents, and global trial operations
• Demonstrated ability to work with CROs and third-party vendors to deliver on scope

Education

• Bachelor’s degree required