Undergraduate degree with practical experience in a related field.
Minimum of 7 years in drug development.
Extensive background in clinical trial conduct and global operations.
Thorough understanding of project and study management processes.
Knowledge of FDA regulations, Good Clinical Practice (GCP), and ICH guidelines.
Experience in process improvement methodologies.
Strong communication and interpersonal skills.
Responsibilities
Influence and collaborate across functions.
Deliver service strategy and standards at project level.
Manage Key Performance Indicators for services provided.
Act as point of contact for daily stakeholder management.
Provide subject matter expertise to study teams.
Work directly with vendor leadership to resolve issues.
Serve as escalation point for ongoing vendor management.
Benefits
Comprehensive health insurance options.
Retirement savings plan with company match.
Generous paid time off policies.
Professional development opportunities.
Flexible work arrangements.
Full Job Description
Opportunity Details
On Assignment Sr. Manager Lab Services
New York, NY
Job Summary
Serve as point person for study team stakeholders across the organization as well as to the relevant vendors.
Collaborates closely with colleagues across CD&O and the broader organization to ensure service level vendor requirements are delivered while ensuring vendor scope is delivered with quality and speed.
Support and ensure vendor risk management, vendor issues management, and general guidance are maintained for all relevant vendors within the service category.
Job Responsibilities
Cross functional influencing and collaboration
Responsible for the delivery of "service" strategy and standards at the project level
Ensure Key Performance Indicators are managed appropriately at the service level.
POC for day-to-day management of stakeholders relating to study management.
Supports Study Teams as a subject matter expert for service level activities
Works directly with vendor counterparts & levels of the vendor leadership for issue resolution.
Escalation point for study teams for ongoing issue management
Qualifications
Educational Background: Undergraduate degree with practical experience in a related field
Experience: At least 7 years of experience in drug development.
Extensive background in clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management.
Understanding of FDA regulations, Good Clinical Practice (GCP), and ICH guidelines; Experience working in process improvement
Ability to manage continuous change and complex projects
Excellent communication
Effective interpersonal skills to ensure productive collaborations
