• In Oncology Early Development, the Clinical Trial Leader (CTL) is responsible to connect science and operations to bring clinical studies to life through the execution of one or more early phase oncology clinical research studies
• Contributes clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives
• The CTL achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges
• Leader of the cross functional study team
• Leads Clinical Study Execution Team Meetings for clinical studies leveraging the clinical schedule; manages the critical path and milestones
• Responsible for the vendor/CRO selection, scope development, management and oversight of external vendors/CROs
• Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures CTMS is up to dat
• Responsible for the development of the clinical study design and associated systems and documents (for example: ICFs, eCRFs, IRT, CSR)
• Responsible for study budget creation and oversight of spend against approved budget
• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
• Proactively identify and address and/or escalate study related issues and opportunities for efficiency
• Decision maker on operational aspects of study execution

Qualifications:

• Bachelor s Degree
• Must have at least 6 years of clinical trial management experience
• Strong background leading and managing oncology clinical trials
• Experience overseeing fully outsourced clinical trials or experience at a CRO
• Demonstrates a high level of core and technical competencies through management of various components of clinical trials
• Possesses good communication skills and demonstrated leadership abilities
• Demonstration of successful coaching/mentoring in a matrix environment
• Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance)
• Study initiation through study completion experience