Manager Clinical Study Lead – Oncology

Manager Clinical Study Lead – Oncology

Requirements

• Minimum of a Bachelor’s degree
• 6+ years of direct clinical trial experience
• Direct experience managing global clinical trial operations
• Experience developing protocols and key study documents
• Technical proficiency in trial management software and MS applications

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery
• Provides operational input into protocol development
• Oversees and provides input to the development of study specific documentation
• Ensures compliance with the clinical trial registry requirements
• Identifies outsourcing needs of the study and leads engagement with vendors
• Provides input into baseline budget and timeline development
• Leads risk assessment and identifies risk mitigation strategies
• Oversees/conducts site evaluation and selection
• Monitors progress for site activation and monitoring visits
• Leads the development of patient recruitment and retention strategies
• Monitors data entry and query resolution
• Ensures accurate budget management and scope changes
• Oversees study drug and clinical supplies forecasting
• Escalates issues related to study conduct, quality, timelines or budget
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees data quality including regular review of data metrics
• Ensures CROs and Third Party Vendors are in alignment
• Ensure clinical project audit and inspection readiness
• Supports internal audit and external inspection activities
• Manages and oversees study close-out activities
• Contributes to clinical study report writing and review
• Facilitates and contributes to study level lessons learned
• Assigns tasks to Clinical Study Management staff
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution
• Responsible for direct supervision of CTM staff
• May be assigned unmasked tasks for studies
• May require up to 25% travel

Preferred Qualifications

• Demonstrated interpersonal & leadership skills
• Ability to understand and implement operational strategic direction
• A data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines
• Ability to influence and negotiate across key stakeholders
• Budget management experience
• An awareness of relevant industry trends
• Ability to build productive study teams and collaborations
• Demonstrated vendor management experience
• Technical proficiency in trial management systems and MS applications
• Experience in global clinical trial operations
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross-functional team leadership and organizational skills