Ashika K. Email and Phone Number

- Aims to promote health and to prevent morbidity and mortality caused by modifiable risk factors. - Monitors and supports the successful delivery of strategically significant programs of work across the NSW Health system- Focus on evidence-informed programmatic and system-level interventions that improve health, reduce health inequity, create healthy environments, promote community action, enable personal health-seeking and recognise the social determinants of good health- Map and facilitate active management of the portfolio of strategically significant projects with a large technology focus including digital integration.

- Work with pillar organisations, local health districts, primary care providers and the non-government sector in the translation of research into clinical practice, healthy lifestyles and illness prevention- develop and support statewide strategic research programs and policy frameworks to enable capacity, capability building and enhance collaboration across NSW health and medical research sector

Demonstrated expertise in clinical trial leadership including project management of all activities required in planning and execution of clinical trial activity from project planning & life cycle management, start-up including ethics, governance and regulatory processes, quality management, budget oversight, and reportingOperational experience in academic / Investigator-initiated clinical trials/commercially sponsored/collaborative group clinical trialsClinical Trial expertise across a variety of interventions and therapeutic areas including oncologyAdvanced knowledge of International Conference on Harmonization (ICH) / Good clinical practice (GCP) guidelines, the National Statement and other relevant Australian and international clinical trial regulations

- planning, executing and reporting on Phase I to Phase IV clinical studies from start up to close out- overseeing performance and quality standards on assigned trials to ensure delivery on time, on budget and in compliance with organisation processes, KPIs, quality standards as well as local regulatory requirements. - create, review and maintain global working practices, standards and templates to support Good Clinical Practice (GCP) inspection readiness. - participate in the development and review of documents such as departmental Standard Operating Procedures (SOPs), guidelines, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, CDISC standards, Quality Assurance/Quality Control, and data validation plans to support GCP inspection readiness. - manage 3rd party vendors as required.-develop /review essential trial documentation, including but not limited to clinical study protocol, monitoring plan, protocol deviation plan, communication plan to ensure compliance with organisation SOPs- drive the conduct of the trial, track and oversee progress and status including but not limited to study start up, monitoring frequency, prompt site issue resolution, TMF maintenance,- manage data at the third party/site level (as applicable); resolve technical and content issues to achieve aggressive database lock targets.- Serious adverse events database reconciliation- contributing to protocols and preparing the Data Management Plan, Case Report Form (CRF) design, CRF completion guidelines, edit checks, database testing and updates throughout the trial lifecycle. - Track and report progress for data management activities with proactive risk identification to ensure timely locking of databases.

- Provide day-to-day medical care for patients in a variety of settings: hospitals (emergency and inpatient) health clinics and local General Practice.