Lead and deliver strategy and implementation projects for banking clients, focusing on credit, real estate valuation, refinancing, risk management and sustainability. Support executive strategy and product development while building strong client relationships and thought leadership.
About the role
- Senior Manager Clinical Study Lead overseeing global execution of complex clinical trials. Leading cross-functional study team and ensuring compliance with regulatory requirements and budget management.
Responsibilities
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight
- Provides operational input into protocol development
- Oversees the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
- Ensures compliance with the 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
- Leads risk assessment and identifies risk mitigation strategies at the study level
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan
- Monitors data entry and query resolution and acts on any deviations from agreed metrics
- Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
- Manages and oversees study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
Requirements
- Minimum of a Bachelor's degree
- Minimum of 8 years relevant clinical trial experience
- Exceptional interpersonal & leadership skills
- Advanced project management skills, cross-functional team leadership and organizational skills
- Strong budget management experience
- Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents.
- Ability to build, lead and develop productive study teams and collaborations.
- Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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