Partnership Liaison; Primary point of contact with an external CRO partner, ensuring alignment with internal requirements/needs. Assisting and guiding discussions required to optimize process and procedures surrounding our joint efforts in trial delivery. Additionally providing overall clinical project management, through leading cross-functional teams. Tasked with on-time delivery of programs/studies at the global level, overseeing outsourcing and budget management.  Primary point of contact, ensuring open communication between functions and internal groups outside of CR&D  Lead multi discipline, global teams, ensuring all relevant functional groups provide input to develop and finalize all study deliverables Successfully navigated several FDA inspections, providing remote and onsite support Successfully coordinated preparations and execution for a multi-study PMDA inspection, on two compounds simultaneously. Ensure standard processes are followed with quality expectation met; deficiencies addressed through corrective action plans Managed and mentored externally sourced resources to support ongoing trials Co-Chair of the Study Management Taskforce, providing a joint forum for Study Management Leads to share information, ensuring common messaging and expectations throughout various therapeutic areas

Manage the execution of investigational drug studies from synopsis through the completion of final study report. Chair the Clinical Trial Team; set team annual objectives and prioritize study activities to guarantee timelines and metrics are met. Ensure open communications between all functional lines.

Managed the execution of investigational drug studies from synopsis through the completion of database activities. Global Study Team Lead; ensured open communications with Medical Research and various global functional teams. Triaged study activities and deliverables to meet time-lines and metrics.

Same overall description as GTL position with Pfizer: Managed the execution of investigational drug studies from synopsis through the completion of database activities. Global Study Team Lead; ensured open communications with Medical Research and various global functional teams. Triaged study activities and deliverables to meet time-lines and metrics.

Clinical Trial Operations Leader for four phase III clinical trials-Co-Leader of the Study Governance sub-team, within the Enrollment Breakthrough Initiative, which decreased the number of monthly reporting committees across functional areas and allowed for quick, critical decisions and maximized the effectiveness of corrective actions-Subject-matter expert and trainer for the Site Management Initiative, tasked with providing instruction to global members of the restructured Global Trial Organization on their new roles and responsibilities-Delivered on-time enrollment of a program with a 91% screen failure rate -Direct the regional site selection process and management of site initiations-Supervised budget negotiations and investigator contracting-Interacted with central labs and CROs

Assisted in the creation and chartering of the Clinical Trial Operations Council, created to ensure standard practices across therapeutic areas. Served as a core team member and aided in the development of standardized processes for the newly formed organization.  -Developed and managed the Trial Execution Plan and trial budget-Managed and approved site payments and reconciliation with budget -Tracked patient enrollment and site monitoring, closeout activities-Coordinated data management activities

Oversaw proper implementation and execution of the protocol through tracking and reporting on recruitment and compliance metrics of investigational study sites-Developed and revised the protocol, study site reference guides, and informed consents -Reviewed site monitoring reports and implemented corrective site action plans to address performance issues

Project Leader for both phase I & II clinical trials, involved in the development of Case Report Forms, Study Site Reference Guides and study time-lines.-Safety Review Team member, assisted the review process through ensuring complete reconciliation of reported Serious Adverse Events -Drafted validations for new Remote Data Capture software -Global Data Validation Team member; wrote and tested new validations for clinical trials to ensure standard protocol compliance throughout the global network