Lynda Atalese

* Oversee the execution of Start Up

(including pre award/bid defense activities) and maintenance for projects adhering to project timelines

* Develop, implement and maintain the Regulatory Start Up Management Plan

* Provide overall guidance and oversight of multi-regional and multiprotocol programs during initial startup and maintenance phase as an integral member of the study management team

• Oversee the execution of Start Up ( including pre award/bid defense activities) and maintenance for projects adhering to project timelines
• Develop, implement and maintain the Regulatory Start Up Management Plan (RSU Plan)
• Ensure collaboration across start up, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Regulatory Start Up Management Plan
• Provide overall guidance and oversight of multi-regional and multiprotocol programs during initial startup and maintenance phase as an integral member of the study management team
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• Identify regulatory complexity and challenges and offer creative solutions to support bid process and subsequent execution of Regulatory Management Plan
• Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents
• Work with Quality Management to ensure quality standards are met
• Mentor and coach colleagues
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines
• Deliver presentations/training to clients and colleagues