[上海]迪哲（江苏）医药股份有限公司

职位：临床监查培训生（上海）
发布时间：2024-11-15
工作地点：上海
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
专业1:药学
专业2:基础医学
职能类别:临床监查员
Participate in the coordination of and contribute to operational activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives during overall study management life cycle in country level.
Participate in CRA training program, if qualified after evaluation after LM, who will participate in site management as CRA role.
Responsibility:
1. Site management
? Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study team to ensure that quality commitments are achieved in a timely and efficient manner.
? Conduct site feasibility assessment.
? Contribute to the selection of potential investigators and leading investigator.
? Contribute to national Investigator meeting.
? Obtain and maintain essential documentation in compliance with international guidelines ICH-GCP, Company procedural documents and local regulations both in the office and at site.
? Actively participate in local Study Team meetings. Share information on patient recruitment and study site progress within local Study Team. Good knowledge in relevant Therapeutic area to train, support and advice Investigators and site staff in study related matters.
? Initiate monitor and close study sites in compliance with Company procedural Documents. Ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.
? Drive performance at the sites.
? Update study related systems with data from sites per required timelines.
? Manage study supplies, drug supplies and drug accountability at study sites.
? Perform source data verification. Proactively identify study-related issues and escalates as appropriate.
? Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.
? Ensure accurate and timely reporting of Serious Adverse Events.
? Work with data management to ensure quality of the study data. Ensure data query resolution.
? Prepare for activities associated with audit and regulatory inspection at responsible sites and/country in liaison with local study team lead and QA.
? Responsible for completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
? Identify and report quality issues along with corrective and preventive actions to Local study leader/equivalent especially when it’s related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients' rights and wellbeing.
2. Management and Relationship Responsibilities
? Provide clear guidelines and share information with investigators on study objectives and procedures to build their understanding of expectations and targets.
? Motivate and support investigators and site staff to achieve target patient recruitment, identifying issues and liaising with site staff to develop solutions.
? Set up the close connection with KOLs and field thought leaders, maintain the good relationship with the cooperated sites.
Requirement:
? Good medical knowledge and basic understanding of the drug development process.
? Fluent knowledge of spoken, read and written English.
? Team oriented and flexible. Ability to manage & prioritize multiple tasks with conflicting deadlines ability to work in an environment of remote collaborators
? Meticulous and detail-oriented
? Ability to travel nationally as required. 公司简要介绍：
公司名称:迪哲（江苏）医药股份有限公司
公司类型:外资（欧美）
公司介绍:迪哲医药（股票代码：688192）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了五款具备全球竞争力的产品管线，两大领先产品处于全球关键性临床试验阶段，其中一款已获批上市。

Dizal Pharmaceutical Co., Ltd (Ticker: 688192 ) is a commercial stage biopharmaceutical company. At Dizal we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. Building on our extensive expertise in translational science and molecular design, we have established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already approved.