nicola burridge
clinical study manager
About
Confident, driven clinical professional with global experience in the pharmaceutical and medical device sectors. Works independently and with teams to develop and implement clinical trials adhering to ICH GCP guidelines and relevant SOPs. Extensive experience in all elements of clinical trials from full scale monitoring, protocol writing and ethics submissions, to results communication. Strong people skills with a focus on developing quality working relationships with internal and external stakeholders.
australia
sydney
pharmaceuticals
clinical monitoring, gcp, clinical trials, ich gcp, edc, oncology, crf design, medical devices, clinical study design, patient recruitment, vaccines, ctms, clinical research, line management, cancer, clinical development, infectious diseases, regulatory submissions, cro
Experience
clinical trials assistant
dainippon sumitomo pharma
senior clinical research associate
stryker south pacific
* Project manager and CRA responsibilities for five clinical studies including full scale monitoring, protocol writing, CRF development, ethics submissions, budgeting, clinical study report writing, manuscript preparation and management of sites from feasibility to close out. * Managed external research projects with clinicians and specialty contractors. * Trained study coordinators and junior registrars on clinical research industry/studies. * Communicated research activities to Marketing, Financial and Regulatory departments.
senior clinical research associate
cancer research uk
* CRA lead on multiple Phase I/II oncology trials (Breast, Ovarian, Solid Tumour, Pancreatic). * Responsible for all monitoring activities from feasibility and site selection through to close out. * Maintained recruitment targets, built strong working relationships with Investigators/site staff, primary CRA contact for the study team/project management. * Led all types of monitoring visits for six studies adhering to ICH GCP requirements. * Mentored and trained new and junior employees. * Owned SOPs and process-review activities when implementing electronic data capture system into Cancer Research UK (InForm Global Trial Management v5). * Successfully prepared clinical sites for audit inspection: no major findings.
clinical study manager
novartis
Novartis provides healthcare solutions that improve and extend people's lives. We use science-based innovation to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicinesNovartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.See our community guidelines: https://www.novartis.com/sites/www.novartis.com/files/linkedin-community-guidelines.pdf
senior clinical research associate
novartis
SCRA/Lead responsibilities for Cardiovascular studies Full monitoring capabilities including site selection, routine monitoring, database lock and close out
Education
university of sydney
nutrition
nicola burridge's Contact Information
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