Senior Manager Clinical Study Lead (Asthma/Allergy)

Role Summary

The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study closeout. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with SOPs and ICH/GCP. This role applies to internally sourced studies and studies outsourced to CROs, with the balance of direct leadership versus oversight varying accordingly. Contributes and drives ongoing process improvement initiatives.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight for the assigned study
• Provides operational input into protocol development
• Oversees and provides input to the development of study specific documentation including but not limited to: CRF, data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Oversees set-up and maintenance of study systems including CTMS, TMF, etc.
• Ensures compliance with clinical trial registry requirements
• Identifies outsourcing needs of the study and leads engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Provides input into baseline timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Leads feasibility assessment to select relevant regions and countries for the study
• Oversees/conducts site evaluation and selection
• Leads investigator meeting preparation and execution
• Monitors progress for site activation and monitoring visits and acts on deviations from plan
• Leads the development and implementation of patient recruitment and retention strategies and acts on deviations from plan
• Monitors data entry and query resolution and acts on deviations from agreed metrics
• Ensures accurate budget management and scope changes for internal and external studies
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to POL and other stakeholders and develops appropriate actions
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Oversees and ensures CROs and Third Party Vendors are aligned and delivering per the scope of work
• Ensure clinical project audit and inspection readiness through the study lifecycle
• Supports internal audit and external inspection activities and contributes to CAPAs as required
• Manages and oversees study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• Contributes to clinical study report writing and review
• Facilitates and contributes to study level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
• May be assigned unmasked tasks for studies, including assisting with masked investigational product, set up and management of unmasked TMF, review of unmasked data in EDC, IVRS issues, and oversight of unmasked clinical monitoring
• Responsible for direct supervision of CTM staff with line management responsibilities including work assignments, performance management, recruitment, development, coaching, training and compliance, and study support/oversight
• May require 25% travel

Qualifications

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

Education

• Bachelor's degree or equivalent required

Additional Requirements

• Travel up to 25% may be required