Tracy Wang Email & Phone Number

Brisbane, Queensland, Australia

Cordis Australia Pty LTD 07/2022 – CurrentRelocated fromCordis (China) Medical Device Co., Ltd 06/2020 – 06/2022Clinical Affairs:- Overall responsibility for pre-market clinical studies- Develop clinical strategies for new products registration- Provide clinical data from other sources for registration without local trials Medical Affairs: - Post-Market/Real World clinical studies- CERs- Public release of content approval- Support HCPs in drafting and publishing consensus and guidelinesClinical Education & Training: - Establish a high-level professional education platform in specific areas- Design and organize clinical education programsHCP engagement: Foster strategic, multifaceted and impactful interactions with HCPs, HCOs and medical societies.Achievements:- Completed a Vascular Closure Device clinical study ahead of schedule when the project was already severely behind schedule; maintained good relationships with the investigators in the trial, engaged them as KOL and speakers for the purpose of product promotion. - Ran a post market study in China with over 20 sites, the study device was an abdominal aortic stent.- Led academic team to collaborate with Beijing Medical Association for expert consensus on VTE prevention in nursing area. - Approved and supported the first IIS in China (IIS: investigator-initiated study). The study device is a lower limb vascular stent. - As the head of Clinical Education & Training, trained more than 40,000 doctors per year, with more than 30 training sessions, and organized about 10 online overseas communicating events per year even under the epidemic.

Beijing, China

- Collaborated with healthcare professionals to deliver high-quality clinical studies.- Oversaw daily activities and interactions with investigators.- Managed clinical operations and procedures and enforced adherence to federal and state regulations and healthcare law requirements. - Administered financial operations and handled budget development, expenditure authorization, accounting, and financial reporting. - Employed active listening and interpersonal talents to effectively interact with various individuals, including physicians, patients, fellow employees and vendors.Achievements:- Ran the clinical study of the flag device of the company - Thoracic Branch Endoprosthesis (innovative product). Saved half of the cost and time as the study leveraged overseas data and local data as a bridge study. - Successfully got approved for VIABAHN Balloon Expandable Endoprosthesis (innovative product) through CER. Developed the clinical strategy and reviewed the CER. - Successfully got approved for Iliac Branch Endoprosthesis through Acceptance of Overseas Data. Used US, Japan, and Taiwan data for China registration. Waived the local clinical trial and saved cost.

Beijing, China

Franchise: Ortho Clinical Diagnostics (became a standalone company from Oct. 2015)Medical and Clinical Affairs Manager -China (2014-2018)Assistant Product Manager of Health Economics – China (2001-2013)- Managed clinical affairs team, developed talents.- Developed clinical strategies for new product registration. - Lead the clinical study designing, finalize the protocol Design and organize the pretests.- Serve as single point of accountability for operational delivery of clinical studies. - Manage and ensure the quality of the clinical trial. - Manage cross functional study teams on planning, execution, and reporting of clinical studies as well as finance, supply chain, legal and other divisions. Achievements: - Pre-market clinical studies: o 2 blood typing reagents (Class III): a rare blood type reagent and a newborn blood type reagent. o 1 infectious disease reagent (Class III): HIV Combo o 3 immune reagents (Class II) o 2 biochemical reagents (Class II) o 2 in vitro diagnosis devices (Class III): blood typing devices. - Post-market study: o Irregular Antibody Study for Chinese Population- Health Economics Program: o The first Eco-friendly device and clinical lab in Asia

Master'S Degree, Social Security

Bachelor'S Degree, Economics