Lalita Harley
Associate Director, Site Mangement, U s Oncology @Bayer
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WORK HISTORY
Associate Director, Site Mangement, U s Oncology @Bayer
Responsible for leading and managing a group of employees within Country Site Management Organization for Phase I-IV global development clinical trials• Accountable to ensure direct reports’ performance and overall site management activities are executed according to Bayer expectations regarding quality, legal, regulatory, and compliance expectations• Accountable for ensuring direct reports have appropriate professional, development, and technical skills to deliver all site management activities• Ensure projects are sourced appropriately by assisting with allocating or hiring appropriate staff to deliver project/study goals by critically analyzing study needs while also managing and measuring the workload requirements of direct reports.• Responsible for managing internal costs associated with direct reports and collaborates with Country Heads of Site Management to prepare and track overall departmental operating budget. Works with direct reports to ensure CLMs are providing accurate data for country study budget• Ensures quality oversight based on quality risk indicators and KPIs; oversee Corrective Actions/Preventative Actions (CAPAs) of direct reports to ensure timely and sufficient resolution• Continuously and proactively identify and propose solutions for process improvement opportunities to Country Head and communicate best practices to entire team• Assess training needs for direct reports, develop and implements training and development plan in a timely manner.
EDUCATION
Washington College
Bacehlor of Science, Biology
University of Maryland Baltimore
Bachelor of Science (BS), Nursing
SKILLS
ABOUT LALITA HARLEY
Dual Degree prepared Registered Nurse with 19 years of progressively advanced clinical research experience including coordinating, clinical monitoring, quality assurance, and project management/clinical trial management skills.Detail-oriented, strategic thinker with excellent analytical skills and the proven ability to prioritize, coordinate and direct multiple tasks with minimal or no oversight. Interpersonal skills fostering a positive team environment and client relationships.
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