Experience

Opthea

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Director Clinical Operations

  • Jun 2022 - Present



Gyroscope Therapeutics

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Sr. Clinical Project Manager

  • Mar 2021 - Jul 2022

  Sr. Clinical Research Project Management of Ophthalmic Gene Therapy studies. Sr. Clinical Research Project Management of Ophthalmic Gene Therapy studies.



REGENXBIO Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Clinical Project Manager

  • Oct 2020 - Mar 2021

  Sr. Clinical Project Management of Ophthalmology Gene Therapy Studies. Manages CRO/Vendor agreements. Oversee eTMF set-up ongoing quality review and final reconciliation of study documents. Ensure all aspects of GCP compliance and audit readiness are maintained. Sponsor quality monitoring/oversight visits to sites and/or CRA performance assessment. Prepare study metrics and provides updates to upper management. Strong understanding of cost drivers and accountable for the development, management, reconciliation of the overall study budget. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Manager

  • Feb 2013 - Oct 2020

  (Formerly Abbott Laboratories). "Ophthalmology device studies" Plans, develops and manages all clinical aspects of clinical studies on new and existing products, Globally. Coordination of cross-functional teams. Line management and mentorship of CRAs and CTAs. Prepares Global Clinical Research Plans with associated budgeting and personnel requirements. Provides Investigator and surgical training on investigational devices. Initiates and participates in process-improvement initiatives. Provides clinical expertise to formulate clinical development plans. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Project Manager

  • Aug 2008 - Jun 2012

  Responsible for execution of studies within budget and on-time. Management of key-customer account in support of process improvement and training to exceed the Clinical Operation client need. Manage overall timeline. Facilitate and participate contract discussions and negotiations for study start-up activities. Ensure consistent with study documentation such as protocol, ICF and regulatory submission. Develop study management plans, and accountabilities including oversight of database maintenance and TMF auditing. Show less

• Lead Clinical Research Associate

  • May 2006 - Aug 2008

  Perform site selection, initiation, monitoring and close-out visits. Manage the progress of the assigned studies. Managing up to 10 CRAs, including development of monitoring plans, timelines and team initiatives. Cross functional responsibilities. SWAT monitor. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.