Senior Manager Clinical Study Lead (Asthma/Allergy)

Role Summary

The Senior Clinical Study Lead (CSL) is responsible for the global execution of assigned large and/or complex clinical trials from study design through close-out, accountable for timelines and budget, and ensuring conduct aligns with SOPs and ICH/GCP. Roles include internal and CRO-managed studies with varying levels of direct leadership versus oversight, and ongoing process improvement initiatives. This role is onsite and not fully remote.

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
• Oversee and contribute to study documentation such as CRFs, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, and statistical analysis plan
• Set up and maintain study systems (CTMS, TMF, etc.)
• Ensure compliance with clinical trial registry requirements
• Identify outsourcing needs and oversee engagement, contracting, and management of required vendors
• Contribute to baseline budget development and management
• Contribute to baseline timeline development and management
• Lead risk assessment and risk mitigation strategies at the study level
• Lead feasibility assessments to select regions and countries for the study
• Oversee site evaluation and selection; lead investigator meeting preparation and execution
• Monitor site activation and monitoring visits, addressing deviations from plan
• Develop and oversee patient recruitment and retention strategies and address deviations
• Monitor data entry and query resolution, addressing deviations from metrics
• Ensure accurate budget management and scope changes for internal and external studies
• Oversee study drug and clinical supplies forecasting, drug accountability, and reconciliation
• Escalate issues related to study conduct, quality, timelines, or budget and implement actions
• Oversee execution of the study against timelines, deliverables, and budget
• Monitor data quality, including metrics, protocol deviations, eligibility violations, dosing deviations, and potential non-compliance
• Ensure CROs and third-party vendors are aligned and delivering per scope of work
• Ensure audit and inspection readiness throughout the study lifecycle; support internal and external audits and contribute to CAPAs
• Manage study close-out activities (database lock, vendor contract reconciliation, budget, TMF, drug accountability)
• Contribute to clinical study report writing and review
• Facilitate study-level lessons learned
• Assign tasks to Clinical Study Management staff and support deliverables
• Participate in cross-functional and departmental process improvement initiatives
• Identify innovative approaches to clinical study execution and continuously improve CTM SOPs
• May perform unmasked tasks (e.g., handling masked investigational product, unmasked TMF, IVRS issues) as assigned
• Directly supervise CTM staff, including workload assignments, performance management, recruitment, development, coaching, training, and compliance
• May travel up to 25%

Qualifications

• Minimum of a Bachelor's degree
• Minimum of 8 years of relevant clinical trial 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, and presentation)
• Proactive, self-disciplined with good time management and prioritization
• Ability to influence and negotiate with diverse stakeholders
• Strong budget management experience
• Awareness of industry trends and global trial operations
• Ability to build, lead, and develop study teams and collaborations
• Vendor management, negotiation, and interpersonal skills
• Technical proficiency in trial management systems and MS Office (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Knowledge of ICH/GCP and regulatory guidelines
• Advanced project management and cross-functional leadership
• Line management experience

Education

• Bachelor's degree (minimum)

Additional Requirements

• Onsite work required; travel up to 25% may be needed