Formed a global team to minimize the CO2 footprint of clinical trials at Novartis. The project was victorious at the One Young World caucus event hosted by Novartis. The team provided guidance and training to Novartis clinical teams to aid them in adopting sustainable processes. I have presented at three congresses regarding sustainable clinical trials representing Novartis. I have also assisted the DNDi group with counsel and insights on sustainable clinical trials. Our team was honored with the Novartis Culture Award for our dedication to reducing CO2 emissions.Set up partnership with Kits4life to repurpose unused laboratory kits and devices for humanitarian aid.

• Management and coordination of cross functional teams across the US, Canada, Europe and Australia. • Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.• Development and update of study management plans.• Pro-active management of study execution and mitigation of risk.• Budget management.• Resource management and assignment requests.• Leadership and oversight of regional and in-house CRAs.• Client and vendor relationship management.• Primary project contact with Sponsor to ensure continuous communication and reporting.• Presentation of project information at internal and external meetings• Organise client kick off meetings, coordinating the various departments to provide a full feedback for conducting the study.Coordinate and present at Investigator meetings in the UK and the US.

• Clinical management of CRAs, vendors and sites to meet study timelines.• Create and maintain CMP for studies• Review reports for CRA visits.• Create data cleaning plan for countries and work closely with DM to ensure DMP is adhered to in order to meet DB lock.• Provide status updates for sponsors on a weekly basis.• Work with CRAs to implement retraining when issues occur.• Work with clinical operations quality and line managers to ensure CRAs are supported and study is being conducted as per ICH GCPManaged SSU teams for EC submissions, contract negotiations and SIV preparation.

Worked in Study Start Up as Regional SSU lead – responsible for SSU groups across Western Europe for 10 countries, driving site ID, ethics submissions and contract negotiations - striving to reduce the start up timelines in each country.

• Perform site selection, initiation, monitoring and close out visits in accordance with study protocols and SOPs• Administer protocol and related study training to assigned sites and monitoring each site regularly to ensure that they are complying with ICH GCP.• Trained and mentored Junior CRAs, completed many accompanied site visits, ensuring the CRAs are trained and supported throughout the study. Set up TCs to ensure team members are clear on requirements for study deadlines; provide support when they are on site with study queries.• Escalate quality issues to the responsible CTL• Ensure safety reporting procedures are adhered to• Manage the progress of the study by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission and data query generation and resolution.• Assist CTL with design of study tools, documents and processes.• Owner and author of Work Instruction document for monitoring in Ireland. This involved liaising with regulatory, start up group, QA and Pharmacovigilance departments, organising teleconferences to discuss the document and ensuring the updates are accurate and concise so that CRAs who monitor in Ireland have a clear instruction on how to work to Irish regulations.

• Supporting clinical project team• Primary contact for sites• Set up 3 new clinical trials at GSK, one of which was the first site globally to recruit a patient. Managed, monitored, conducted close out visits and archived various clinical studies. Overall had responsibility for 6 clinical trials• Responsible for collating documents for regulatory submissions for studies in Ireland.• Had overall responsibility for setting up and management of the budgets for my studies and ensuring the study was conducted as per the budget agreement. Set up tracking spreadsheets to monitor Investigator payments etc.• Manage the progress of the study by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission and data query generation and resolution

• Completed 12 month CRA experience setting up studies from pre study, initiation, monitoring and close out for phase II and III trials all over Australia and New Zealand.• Trained and very competent in using electronic CRFs.• Assisted in setting up two Investigator meetings, Dallas Texas and in Sydney Australia• Worked closely with CTAs and new CRAs training and mentoring them on the study.• Designed newsletters and assisted with monthly reports for the client by updated various status reports weekly and monthly.

• Completed 9 months extensive training attaining various industry recognised certificates and since then I have initiated, monitored and managed trials from Phase I to III.• Completed ethics submissions to MRECs and LRECs for various studies.• Lead CRA for UK office for 23 sites (73 patients) for global Non Hodgkin’s Lymphoma study.• Audited a Phase I site on behalf of the sponsor provided detailed report on the processes that the site use and made recommendations for improvements.• Designed CRFs and Patient Information Sheets for 2 different studies.• Conducted and participated in weekly teleconferences for various studies ensuring that all study deadlines were being met. Coordinated the other CRAs to ensure updates of weekly reports for Project Managers were completed on time.• Trained and mentored two trainee CRAs for 9 months.• Was awarded secondment to new phase I research unit in Madison Wisconsin USA where I was responsible for monitoring phase I and II studies in the CCRU for 3 months