*Responsible for ongoing supervision and training of clinical research coordinators*Implement training programs for CRAs and related clinical staff*Determine project schedules and document progress*Responsible for assignment of staff based on identified Center needs and to ensure optimal Center operations*Demonstrate expertise in Good Clinical Practice (GCP) and federal regulatory guidelines to ensure the highest quality research standards are met*Responsible for clinical trial reporting, participation in audits, study monitoring visits, and drafting reports and responses as necessary*Ensure all faculty and staff adhere to GCP and have appropriate training in delegated responsibilities*Facilitates timely and responsive communication and proactive responsible decision making

*Reviewed and approved Clinical Trial Agreements and other contracts required to conduct programs that cannot be completed by the vendor*Approved final case report form design*Led the vendor selection team and worked closely with Strategic Sourcing personnel to identify and manage CROs, vendors, and consultants*Read, understood and adhered to organizational Standard Operating Procedures (SOPs)*Participated in the modification of company SOPs and/or Process Documents related to the therapeutic team*Reviewed and provided recommendations to management on operational procedures, by participating in process improvement initiatives*Responsible to ensure sites were GCP compliant and followed local and regulatory guidelines. *Demonstrated leadership skills and the ability to solve problems proactively.

*Managed and led cross-functional study teams, including vendors*Provided accurate and up-to-date study information within teams and other relevant tracking systems and provided regular updates of study progression*Led feasibility assessment and selection of countries and sites for study conduct*Ensured set-up and implementation of effective investigator and site monitor training; coordinated operational and therapeutic area training for internal and external study team members*Clinical project management of a clinical study*Created and drove study level timeline*Developed overall feasibility concept and enrollment plan