类别：药物研发
待遇：100万
职责业绩:
- Medical and safety supervision of assigned clinical project(s) from both a medical and scientific perspective.

- Act as medical safety liaison between the investigators and the internal clinical operations team.

- Medical oversight of trials to ensure protocol and regulatory guidelines are followed.

- Interact with investigators intermittently during study conduct to understand any recruitment and medical challenges and provide suggestions.

- Preparation and Review of study documents Protocol ICF CRF and CSR to ensure safety regulatory and ethical compliance

- Resolution of medical and safety related queries from sites and project team.

- Training on handling of AEs/SAEs and safety reporting to study site team.

- Initial safety assessment as to whether AEs/SAEs meets definition of events that requires expedited reporting (SUSAR) and review/editing of narratives

- Provide assistance to the project manager to resolve the queries from the regulatory and/or the ethics committees.

- Assist project team during SQVs and SIVs.

- Continuous Medical Monitoring of trials which include eligibility assessment general protocol questions and safety and study investigational product related questions review of lab reports waiver requests major protocol deviations/violations assessment and regular follow up of enrolled patients.

- Presentation on protocol and study conduct wherever required

- Interaction with regulatory authorities.

离职原因：离家太远

待遇：80万
地点：北京-昌平区


- Medical Review: Medical reviewer for 2 phase III liver cancer studies. Responsible for protocol and ICF review, Medical (safety) data review, AE/SAE review, medical coding review, SAE reconciliation, protocol deviation review.

- Lead the DM team (1 staff) to supervise and follow the activities performed by the CRO and ensure an efficient implementation of outsourced clinical trials in adherence to agreed processes, standards, GCP, SOPs and timelines. Provide quality data output at the completion of a clinical trial. Responsible for the DM vendor selection, budget control, contract negotiation.

离职原因：个人发展

类别：外商独资外企，制药/生物工程


职责业绩:
- Act as the medical monitor of Asia pacific region for global oncology studies.

- Work with Medical to develop, review and finalize study protocols, IB, ICF, medical monitoring plan, IRB/EC documents and CSR. Contribute to the review of SAP and CRF.

- Provide medical and scientific expertise to project teams, provide training on protocols and other medical/safety related topics. Answer medical and safety related questions from sites and project team.

- Participate and present in investigator meetings.

- Conduct ongoing medical and safety data review during study conduct, including eligibility criteria, clinical lab data, AEs/SAEs, vital signs, concomitant medications, medical coding and protocol deviations.

- Collaborates with internal and external partners, such as clinical investigators, regulatory authorities, and EC, etc.

类别：外商，生物医药
职位：data manager, data reviewer
部门：数据管理中心
职责业绩:
- Medical reviewer: Responsible for the safety data review of two global phase 3 studies, act as the medical expert to comment on the safety data and in the data review and surveillance meeting. Responsible for the review and SAE reconciliation, medical coding review, safety data review. This work takes 50% of my time.

- Senior Clinical Data Manager: Lead a team of 8 data managers to perform two global phase 3 studies. This work takes 50% of my time.

类别：外商独资外企，医疗/保健/美容/卫生服务
部门：亚太临床数据中心


- Worked on 4 global multi-center studies, responsible for the clinical data entry, data reviewing and central lab data reconciliation, ensure that Data Management quality and timelines.

- Collaborate with the trial team including the CRA and investigators, to ensure the quality, accuracy and effectiveness of the clinical data.

- Have data management experiences on several multinational phase Ⅲ and Ⅳ clinical studies such as cardiovascular disease, hypertension, osteoporosis, diabetes mellitus, etc.

- Act as the DPL of 2 multi-center global trials, responsible for the daily communication with CRAs and study teams, provide constructive feedback on data review plan and data management issues to study teams, provide instructions to CRA on data management in InForm System (EDC) through email and TC. Communicate timelines and provide mentoring and ensure team members are following appropriate procedures and completing tasks as scheduled. Ensure the data quality and DM metrics and timelines

- 2003/8-2004/5:

Cardiologist. Responsible for the treatment of inpatients. The diseases treated are as follows: primary hypertension ， acute and chronic heart failure ， cardiac arrhythmia ， coronary heart disease ， angina pectoris ， cardiomyopathy ， hyperlipidemia ， post CABG surgery. Be responsible for the treatment of patients in the ICU.

- 2004/5-2004/12:

Respiratory physician ， responsible for the daily treatment of inpatients. Gained many experiences in treating of acute upper respiratory tract infection ， pneumonia ， respiratory failure ， COPD ， pulmonary encephalopathy ， especially in the treatment of severe pulmonary infections.


- 2005/1-2007/10:

Physician in the ward of internal medicine ， gained a lot of experiences in treating severe infection ， coronary artery diseases ， cerebrovascular diseases ， diabetic mellitus ， hypertension ， advanced tumor disease ， etc. Participated and instructed the treating of very emergency diseases such as acute and chronic respiratory failure ， acute heart failure ， multi-organ failure ， DIC ， acute and chronic renal failure ， heart infarction and severe infection. Responsible for the daily treatment and medical care of the patient in ICU. Communicate proactively with the patients and ensure the collaboration of the patients.

- Passed the Beijing University resident test. Passed the Attending physician's test of Beijing and got the certificate of attending physician.