Senior Manager Clinical Study Lead
The Senior Manager 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 close out.
This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). The balance of direct leadership versus oversight will vary accordingly.
A typical day in this role looks like: leading cross-functional study teams responsible for clinical study delivery and serving as the primary point of contact for leadership and oversight for assigned studies. This includes providing operational input into protocol development, overseeing and providing input to the development of study-specific documentation, and ensuring compliance with clinical trial registry requirements.
Key responsibilities include:
• Identifying outsourcing needs of studies and leading engagement, contracting, and management of required vendors
• Providing input into baseline budget development and management
• Leading risk assessment and identifying risk mitigation strategies at the study level
• Overseeing site evaluation and selection
• Monitoring progress for site activation and monitoring visits and acting on any deviations from plan
• Ensuring accurate budget management and scope changes for internal and external studies
• Overseeing the execution of clinical studies against planned timelines, deliverables, and budget
• Overseeing data quality, including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Managing and overseeing study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• Contributing to clinical study report writing and review
• Facilitating and contributing to study-level lessons learned
This role has a 3-day onsite minimum requirement and is not eligible for remote work. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
Key qualifications include:
• Exceptional interpersonal and leadership skills
• Advanced expertise and implementation of operational strategic direction and guidance for respective clinical studies
• Expert knowledge and a data-driven approach to planning, executing, and problem-solving
• Strong budget management experience
• Ability to build, lead, and develop productive study teams and collaborations
• Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
Minimum education and relevant experience required: Bachelor's degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.