Description

In this role, you will lead the global clinical operations team, ensuring high-quality site maintenance services through strategic planning and collaboration. Your day-to-day responsibilities will include mentoring staff, analyzing data for effective resource forecasting, and driving innovative solutions to enhance site processes.

Requirements

• •BS degree or international equivalent in life science
• •Extensive experience (≥ 8 years) in Clinical Operations, Project Management, study start-up, site budgeting and contracting, or trial optimization
• •More than 5 years of direct responsibility in site management and oversight of clinical research studies
• •Expertise in clinical trial regulations and ethics committee submissions
• •Expertise in site contract and budget amendments administration
• •Expertise with leading edge trial optimization vendors, tools, and methods
• •Experience in line management and working in a matrix environment
• •Proficiency with software models and database structures
• •Expertise in principles driving site maintenance strategies including site contract amendments
• •Direct experience in the pharmaceutical industry or related field
• •Ability to demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational delivery
• •Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team
• •Ability to explain data and facilitate decision making processes to be data driven

Tasks

• •Oversee strategic planning for global site regulatory activities
• •Manage budgeting and contracting maintenance tasks
• •Collaborate with internal and external stakeholders
• •Provide guidance and mentorship to assigned staff
• •Analyze clinical trial intelligence data for resource forecasting
• •Support priority projects through study closure
• •Champion innovative processes and methodologies for site services
• •Partner with CROs and Clinical Operations teams to improve metrics
• •Train Site Start Up and Maintenance Teams on efficient planning
• •Ensure consistent standards across project portfolios
• •Drive implementation of solutions to enhance site maintenance
• •Leverage industry tools for timeline and performance data
• •Monitor adherence to deliverables at country and site levels
• •Lead cross-functional site maintenance teams
• •Serve as a point of escalation for issue resolution
• •Model Takeda’s values in all interactions