Senior Manager Clinical Study Lead (Asthma/Allergy)

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 close out, ensuring timelines, budget, and conduct in accordance with SOPs and ICH/GCP. Role may involve internal studies or CRO-led studies, with varying balance of direct leadership and oversight. Focus on process improvements and continuous enhancement of trial management practices.

Responsibilities

• Lead the cross-functional study team responsible for clinical study delivery and serve as the primary point of contact for leadership and oversight for the assigned study
• Provide operational input into protocol development
• Develop and oversee study documentation (CRFs, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, statistical analysis plan, etc.)
• Set up and maintain study systems (CTMS, TMF, etc.)
• Ensure compliance with clinical trial registry requirements
• Identify outsourcing needs and manage vendor engagement, contracting, and management
• Contribute to baseline budget and timeline development and management
• Lead risk assessment and mitigation strategies at the study level
• Lead feasibility assessments to select relevant regions and countries
• Oversee site evaluation/selection and investigator meeting preparation/execution
• Monitor site activation and monitoring visits, addressing deviations from plan
• Develop and implement patient recruitment and retention strategies and monitor deviations
• Monitor data entry and query resolution, addressing deviations from metrics
• Manage budget and scope changes for internal and external studies
• Oversee study drug/clinical supplies forecasting, accountability, and reconciliation
• Escalate issues to Program Operations Leader and implement actions to address issues
• Oversee execution of the study against timelines, deliverables, and budget
• Monitor data quality and review data metrics, protocol deviations, eligibility and dosing deviations, and potential non-compliance
• Ensure CROs and third-party vendors align with the scope of work
• Ensure audit and inspection readiness throughout the study lifecycle; support internal audits and external inspections and contribute to CAPAs
• Manage study close-out activities (database lock, vendor contract reconciliation, budget, TMF, drug accountability)
• Contribute to clinical study report writing/review and study-level lessons learned
• Assign tasks to Clinical Study Management staff and support their deliverables
• Participate in cross-functional/process improvement initiatives
• Identify innovative approaches to clinical study execution and continuously improve CTM SOPs
• May perform unmasked tasks related to investigations and related systems; provide oversight of unmasked monitoring
• Supervise CTM staff, including assignments, performance management, recruitment, development, coaching, training, and compliance
• May travel up to 25%

Qualifications

• Exceptional interpersonal and leadership skills
• Advanced expertise in operational strategic direction for clinical studies
• Data-driven planning, execution, and problem-solving capabilities
• Strong verbal, written, and presentation communication skills
• Proactive, self-disciplined with ability to meet deadlines and prioritize
• Ability to influence and negotiate with diverse stakeholders
• Strong budget management experience
• Awareness of industry trends
• Ability to build, lead, and develop productive study teams
• Advanced negotiation and interpersonal skills for vendor management
• Technical proficiency in trial management systems and MS Office applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Extensive experience in global clinical trial operations with knowledge to contribute to protocol and key documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Advanced project management, cross-functional leadership, and organizational skills
• Line management experience

Education

• Minimum: Bachelor's degree
• Experience: At least 8 years in relevant clinical trial roles