Guang Wen

2021.5

Covers the position as PM/COM in past work, also responsible for cross functional communicate, KOLs’ visit. Accountable for leading the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation. Familiarize with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.

From sep2016, as a PM joined in Bestudy. Responsible for two clinical trials and some self-inspections which sponsored by AstraZeneca. Project Management： Covers the position as PL in Novartis, but also responsible for HRG submissions, PD and MVR review, progress following, budget and risk controls. Quality Audit: In addition to ensure the quality of the two trails, also participate in some registered trails of self-inspection. For example: Review the HIS system, protocol, MVR, important documents and related template for QC, and review the CAPA of the sites. And do the best effort to ensure the product can be successfully passed the CFDA’s audit.

From Aug.2011 to Aug.2012 as C-CRA joined in Novartis Medical Affairs Clinical Operation, in Aug.2012 transferred to Novartis as SCRA for the last year’s excellent performance Project Management： From 2013 to the end of 2015, as a PL involved in a neurology project in Southern China. Mainly from speed, quality and budget three aspects of the project management and control. Quality Audit& Risk Control: • For the projects quality are good enough in internal quality audit and the third party audit, so chose to be member of Novartis QC Team, and participated in setting up internal quality control criteria, SOP updated, and finished several CRA and PM working model, including time management model, project expense management and risk control etc. •During in the QC Team’s three year, attended a CO-MO each month to check the other colleague’s project and gave solutions to the corresponding problems.  Participate in self-inspection of several registered clinical projects. Project Experience: From 2010 till now, participated and accomplished in the projects as the following: •area: cardiovascular medicine, endocrine, organ transplant, neurology, ophthalmology, orthopedics and respiration. •2010---2012 Responsible for the 8 sites in cardiovascular medicine and trialed about 400 subjects. •2012---2015 Responsible for the 9 sites in endocrine and trialed about 120 subjects. •2012---2016 Joined in several organ transplant projects, including IIT and NIS. •Took part in several projects in ophthalmology, orthopedics, neurology and respiration. Related Trainings: •Internal trainings: Systematic training in Novartis SOP and ICH-GCP, Novartis internal compliance training, and finished the related test. •External trainings: From 2011---2016 attended Novartis University Leadership and influence training, effective communication course, and got certificates. In 2011 attended the training from CFDA and GCP.

• As C-sCRA joined in Novartis Medical Affairs Clinical Operation, and mainly work was the phase IIII clinical trial. • Main work contents: Joined in the projects Preliminary investigation, communicate with the hospital about contract, deliver EC, monitor the project progress, quality control, hand up SAE, organize external meetings, close sites and drug safety information collection etc. • Attended RPS ICH-GCP Global training.

Project Management： • Site selection, budget negotiation and organizing investigator meetings and so on. • Verify whether the investigational product is supplied, stored, distributed and returned in accordance with relevant regulations, and correspondingly recorded. •Insure that all the clinical research related records are veracity and integrality. All the important documents should be archived. Monitoring: •To perform clinical monitoring activities of clinical projects in a timely and effective manner according to SOPs and ICF GCP Guidelines. Customer Maintain •Keep positive relationship with sponsor and investigator. Other work for clinical operation department •Clinical research or marketing research questionnaires. Update and keep personal training record, help the Business Department to quote, etc.

1.Worked as a monitor in some projects. 2.Preparation, initiation and monitoring the clinical practice according to the PM's guide and assist to finish the related document about the practice. 3.Joined in drafting and revising the project proposal, setting up contracts,maintaining relationship with sites,submitting EC data,monitoring project schedule, organizing investigator meetings etc.