1. Ensure timely deliverable of a DM SAS Programming group with high quality and compliance with industry guidelines, regulatory requirement, SOPs in clinical trials.
2. Streamline working process and improve efficiency.
3. Review or develop DM documents include but not limited eCRF, Edit Check Specification, Data Transfer Agreement, SDTM documents and so on following SOPs
4. Develop SAS program for non-EDC edit checks, listings for data review, external data integration and reconciliation etc.
5. Create aCRF, Mapping Specification, metadata, SDRG etc. for SDTM package. Develop SAS program for SDTM package and QC of SDTM package
6. Design SAS macro system and develop SAS macro
7. Design, build and maintain metadata repository
8. Create and/or review related documents

1. Extensive experience in DM SAS programming
2. Education: Bachelor or Master Degree in Biostatistics, Statistics, Epidemiology, Mathematics, or Computer Science other scientific field (or equivalent theoretical/technical depth).
3. Good communication skill, project management and/or people management skill
4. Advanced clinical trial knowledge and good understanding on DM processes
5. Extensive knowledge of CDISC standards include but not limited to CDASH, SDTM, Define etc.
6. Excellent in Oral and writing English

职位描述：
Position Summary:
Responsible for the planning and execution of statistical activities in support of clinical studies,managing a team, training the new hires, and interviewing the candidates.

Basic Responsibilities:
1. Study Design and Statistical Sections Writing in Protocol
2. Sample Size and Power Calculation in Different Types of Primary Endpoints
3. Generate the Randomization Number per Protocol
4. Write and Review SAP/TLF Shells
5. Review eCRF, Annotated eCRF
6. Preparing ADaM Specifications
7. Creating and Validating ADaM Datasets
8. Creating and Validating TFLs
9. IDMC/DSMB Supporting as Third Party for a Study
10. Writing SAR and Supporting CSR
11. Blind Review Meeting Preparation
12. Host Study Team Meetings
13. NMPA/FDA Inspection Supporting
14. Train and Develop Junior Staff
15. Communication with Regulatory Agencies
16. Interview
17. Resource Planning and Management

职位要求：
Experience and Capability in At Least 5 of the Following Items:
1. Real and Successful Experience in FDA/NMPA Submission
2. Efficacy ADaM Datasets and Analysis Outputs in Lymphoma Study
3. Statistical Simulation and Be Good at Interpreting the Results
4. Multiple Imputation (Non-monotone or Monotone Missing Data Checking, MaR Patterns,MCMC)
5. Meta Analysis and Meta Regression
6. Pooled Analysis
7. Non-inferiority Margin Determination
8. Equivalence Margin Determination
9. ABE and RSABE Method in BE Study
10. Alpha Spending in Sequential Tests and/or Multiple Primary Endpoints
11. Multiplicity and Type I Error Rate Control
12. MRCT Study Design (Simultaneously or Two-Stage)
13. Bridge Study Design (Weighted z Statistics or Bayesian Approaches)
14. Statistical Modeling in Finding RP2D in Oncology Trials (Bayesian Methods with Joint Assessment of Efficacy and Toxicity)
15. Heterogeneity and Subgroup Analysis
16. Know Well of Oncology Dose Escalation Study Design (3+3, m-TPI, CRM, BOIN, etc.)

QUALIFICATIONS:
· Education
Master or PhD in Statistics, Medical Statistics, Mathematics or other scientific fields
· Experience
6~15 years of experience as statistician with Master degree, or, 4~10 years with PhD degree, preferably in a global

SKILLS REQUIRED:
· Oncology experience is a must
· Fast learning
· Extensive clinical knowledge and strong SAS programming skills
· Good in oral and writing English
· Good in presentation
· Strong sense of and well know about the guidelines in NMPA/FDA
· pharmaceutical/CRO company

1. 参与临床项目竞标，分析医学研究策略，制定临床研究开发计划
2. 全面负责临床研究项目的医学工作
2.1. 临床试验相关材料的撰写和翻译，如临床研究方案、研究者手册（IB）、临床研究综述、临床研究报告等。
2.2. 与注册及临床运营团队合作，根据临床试验项目的关键时间节点完成注册相关医学材料的准备和递交
2.3. 配合注册团队，与临床研究监管机构的沟通和交流，对其提出的问题做专业的回复和解答。
2.4. 协助相关部门执行临床试验启动、预算控制、电子数据表格的制作、数据质量管理。
2.5. 对临床试验进行过程中的数据、方案违背（PD）、不良事件（AE）等进行医学审核。
2.6. 对CRA和研究中心提供医学支持，及时回答提出的医学问题，并做好整理和记录。
2.7. 与相关领域的专家讨论研究方案和相关专业问题，参与AB会
2.8. 医学研究论文的撰写、审校和投稿。
3. 文献检索与解读，向内部人员或客户提供最新的疾病和产品知识。
4. 协助制定和优化医学部工作SOP、WI和QD；自觉与质控、数据管理、统计和SMO等部门建立良好合作，必要时协助制定部门间合作工作流程，不断提升工作效率。
5. 招募并发展团队，设定、管理团队目标；向内部同事提供医学知识培训和研究方案培训，必要时进行外部培训。
6. 参与其它医学相关工作。

1. 学历：医学或医学相关专业，硕士或以上学历。
2. 至少5年以上制药行业或CRO公司医学研究、医学项目管理或医学写作工作经验,至少一个完整的临床研究项目经验。
3. 具有较强的自我学习能力、良好的逻辑思维能力和独立开展工作的能力。
4. 熟悉ICH-GCP，对中国医药政策法规有一定的了解。
5. 熟练操作电脑和医学写作常用的办公软件，如Adobe Acrobat、图像处理软件、Microsoft Office (Word/Excel/Powerpoint)、文献管理软件、Graphpad Prism等。
6. 良好的英语听说读写译能力，听说能力应达到基本沟通的水平。
7. 良好的组织协调、人际关系沟通能力。
8. 良好的分析、计划、执行能力。

JOB DUTIES / RESPONSIBILITIES:
This position’s main responsibility is project management in accordance with company’s policies,
sponsor contract/requirements under applicable laws and regulations.
This position routine work is plan and Lead the Delivery of all components of a clinical study to
time, cost, and quality from study specifications through study closeout activities and/or new
drug/product approval by authority accordance with signed company contract with the sponsor.
1. Study delivery
• Planning and leading the delivery of all components of a clinical study to time, cost, and
quality per company policies and contract with the sponsor
• Conduct clinical study management related work according to company Standard
Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws
and regulations
• Form a motivated and aligned study team that delivers the study results on or ahead of
agreed timeline with high quality & cost-effective
• Work with Line Managers/other managers to identify resource need and secure
resources from clinical operations and/or various departments
• Prepare and deliver study execution strategy, including setting study
milestone/timelines, develop recruitment strategies, quality control strategies, cost
control strategies
• Leading/preparing/contributing/training to the delivery of Clinical Study Protocol, and
delivery of other study documents (e.g. Protocol amendments, inform consent
form/amendments, site feasibility/selection package files, EC package files, other study
files, etc.)
• Produce study trackers, tools, forms and other study specific documents per study
needs
• Proactively identify risks to the project, escalate as appropriate and follow through to
resolution, develop &manage contingency risk plans to assure timely delivery to quality,
budget & time and escalate issues to stakeholders as appropriate
• Leading/managing/contributing/discussing with internal/external study
team/members/stakeholder for study status sharing, study reporting, study plan
making, documents drafting, issues escalading/resolving/tracking until closed, and/or
other stakeholders related activities
• Leading/deciding/participating in the negotiations and selection process of external
service providers/vendors per study needs
• Contributes in steering committees, submission assembly teams, regulatory defence
teams, contribute to Advisory Boards, and other activities regarding study, if needed
• Develop project management plan from time, quality and cost aspect per company
policies and/or sponsor requirements
• Leading/Supporting/approving site selection, initiation, monitoring, and closure activitiesShanghai Bestudy Medical Technology Co., Ltd Version 3.0, 01 Mar 2020
Job Description _ PM 2 / 3
• Leading/Supporting/approving study negotiation of budgets and site contracts, if
applicable
• Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings
• Leading/contributing study trainings to team member in specific therapeutic areas,
disease, protocol and other study specific processes per study needs
• Track and manage the assigned studies, work closely with study team member to
manage the planning, preparation, execution, and reporting of clinical trials ensuring
the time, quality, cost & consistency and integrity of data and safety of the subjects
• Focus on end results to be achieved, using metrics, key performance indicators and/or
other tools to manage individual and team performance within clinical studies
• Review/approve CRA's monitoring visit reports, conduct accompany site visit,
guide/coach CRA resolve issues and other activities during study executions from time,
quality, cost perspectives
• Leading/tracking/managing the study Trial Master Files (TMF) were timely and
appropriate collected, archived and transfer to sponsor per study requirements
• Leading/tracking/managing the study budget/cost were appropriate applied, arranged,
forecasted, paid, invoice collection base on aligned with sponsor and/or company
policies
• Acting as monitor per business/clinical trial needs to improve whole team/individual
capabilities, efficiency, a clinical trial execution, quality, process initiatives and/or other
purposes, if needed
• Conduct any other activities regarding study delivery or line manager assigned
2. Admin works and others
• Participate in Bidding activities and prepare presentation for clinical operation part if
necessary
• Interacting with CRM/CTA lead/others for sharing/improving whole team/individual
performance/capability and/or other purposes
• In liaison with Line Managers to support individual professional development through
mentoring, training and other methods
• Work with other members of the organization to share knowledge, experiences and
best practices
• Contributing/leading the whole function develop, quality, process optimization and/or
other initiatives, if applicable
• Evaluate application rationality and approve/reject subordinator’s business travel
application, and/or other activities per company policies and clinical trials needs
• Conduct any other activities which line manager assigned

• Major in clinical medicine/nurse/ pharmacy/ pharmacological
or other related, clinical medicine/nurse was preferred
• At least bachelor’s degree, Master and above was
preferred. or other equivalent education background
Experience
• At least 6 years or above clinical trial working experience in
CRO/Pharmaceutical company or equivalent experience
• Candidates with Clinical research experience in
multinational pharmaceutical companies/multinational CROs
or candidates with 1year line manager/project manager
working experience was preferred
• Candidates with PMP training certificate was preferred
• Familiar with GCP, ICH-GCP and other clinical operation related guidelines/laws and
regulations
• Familiar with drug development related laws and regulations knowledge
• Familiar with project management skills and basic people management, or equivalent
manager level knowledges or skills
Language Ability
• CET-4 and above or equivalent fluent English in reading, writing and speaking, candidates
good at several foreign languages was desirable
Computer Literacy
• Proficient with laptop, familiar with varies conference systems (e.g.: Skype, Webex, etc.)
• Familiar with Microsoft office software (Word, Excel, Power Point, etc.) or equivalent
software familiar
Others
• Able to work at sites and frequently travel
• Good planning and implementation capacity
• Good communication skills and familiar with kinds of communicate methods
• Good coaching and guiding skills, good organization and problem-solving ability
• Team-work spirit, ability to build and maintain efficient working relationships with colleagues,
managers and customers
• Performance driven, keeping learning, self-motivated, accept challenges and work under
pressure

1. Conduct clinical site management related work according to company Standard Operation
Procedures (SOP), Good Clinical Practice (GCP), and other authority laws and regulations
2. Conduct and/or assist with site for study filling, initial EC submission/ EC opinion responds,
clinical study agreement negotiation and others according to protocol and company SOPs
3. Acting as the main line of communication between the sponsor and the investigator
accordance with contracted scope of work
4. Conduct site selection (if applicable), site initiation, routine monitoring and close-out visits in
accordance with contracted scope of work
5. If applicable, may be accountable for supporting developing project subject recruitment plan
on a per site basis. Work with sites to adapt, driving and tracking subject recruitment plan in
line with project needs
6. Conduct monitoring visits and site management activities for a variety of protocols, sites
and therapeutic areas
7. Administer protocol and related study training to assigned sites and establish regular lines
of communication with sites to manage ongoing project expectations and issues
8. Evaluate the quality and integrity of study site practices related to the proper conduct of the
protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
9. Manage the progress of assigned studies by tracking regulatory submissions and approvals,
recruitment and enrollment, case report form (CRF) completion and submission, and data
query generation and resolution, safety information submission etc.
10. Create and maintain appropriate documentation regarding site management, monitoring
visit findings and action plans by submitting regular visit reports, generating follow-up letters
and other required study documentation.
11. Build awareness of features and opportunities of study to site
12. Collaborate and liaise with study team members for project execution support as
appropriate.
13. Other works which line manager or company assigned

• Major in clinical medicine/nurse/ pharmacy/ pharmacological
or other related, clinical medicine/nurse was preferred
• At least junior college education, bachelor’s degree and
above was preferred. or other equivalent education
background
• Previous working experience in clinical research related
industry such as in hospital/medical institute/Contract
Research Organization (CRO)/pharmaceutical or other
similar
• At least 1year or above clinical trial working experience in
CRO/Pharmaceutical company or equivalent experience
Technical/skills Training
• Familiar with GCP and International Conference on Harmonization (ICH) guidelines
• Familiar with drug development related laws and regulations knowledge
• Candidates with authority GCP training certificate was preferred
Language Ability
• CET-4 and above or equivalent fluent English in reading, writing and speaking
Computer Literacy
• Proficient with laptop
• Familiar with Microsoft office software (Word, Excel, Power Point, etc) or equivalent
software familiar
Others
• Able to work at sites and frequently travel
• Strong written and verbal communication skills
• Good organization and problem-solving ability, more detail and accuracy attitude during
daily work
• Team-work spirit, ability to build and maintain efficient working relationships with colleagues,
managers and customers
• Self-motivated, be willing and encourage to accept challenges and work under pressure

Responsible for the planning and execution of statistical activities in support of clinical studies, managing a team, training the new hires, and joining the interviews.
1 Study design and sample size calculation
2 Statistical simulation
3 Generate the randomization number per Protocol
4 Write and review SAP/TLF shells
5 Review eCRF, annotated eCRF
6 Creating and validating ADaM datasets
7 Creating and validating TFLs
8 IDMC/DSMB supporting
9 Writing SAR and supporting CSR
10 Blind review preparation
11 Host study team meeting
12 CFDI inspection supporting
13 Train and develop junior staff
14 Communication with regulatory agencies
15 Interview
16 Resource management
17 People manager

1 Contacts inside and outside the Company: Biostatistics and Programming, Clinical Team, Data Management Team, Clinician and Pharmacist Team
2 Master or PhD in statistics, medical statistics, clinical epidemiology, mathematics or other scientific field (or equivalent theoretical/technical depth)
8~10 years of experience in statistical programming or statistician with Master degree
5~8 years with PhD degree, preferably in a global pharmaceutical/CRO company
3 Extensive clinical knowledge and strong SAS programming skills,Good in Oral and writing English
4 Oncology experience is highly preferableManagement experience is a plus

Position Summary:
Responsible for the planning and execution of programming activities (development, quality
control and documentation) in support of clinical studies, training the junior team members,
maintaining the programming system and platform, and join the interviews.
Principle Responsibilities:
1, Plan programming deliverables for a single project.
2, Develop SAS programs in support of complex clinical trial activities.
3, Review and provide input into project requirements.
4, Develop detailed programming strategy.
5, Provide project specific guidance to programming team members.
6, Drive programming activities to ensure quality and on-time deliverables.
7, Interact with sponsors to assign and review programming deliverables
8, Mentor the junior statistical programmer
9, Develop and maintain the programming system and platform (more than SAS macros)
10, Interview of new candidates
11, Scope of responsibility
a. Plan and execute programs for a single project.
b. Deliver individual SAS programming deliverables of high complexity within a
single project.
c. Demonstrate expertise in technical/programming skills.
d. Demonstrate knowledge of clinical trial activities.
e. Team leadership skills
f. Mentor and training junior staff
g. Developing and maintaining the programming system and platform
h. Interviews
Principle Relationships:
Contacts inside and outside the Company: Biostatistics and Programming, Clinical Team,
Data Management Team, Clinician and Pharmacist Team

Bachelor or Master degree in statistics, medical
statistics, clinical epidemiology, computer science,
mathematics or other scientific field (or equivalent
theoretical/technical depth).
8 years experience programming with B.S. degree,
or,
6 years with Master degree, preferably in a global
pharmaceutical/CRO company.
Extensive knowledge of SAS programming language
Good in Oral and writing English
Management experience is highly preferred

Position Summary:
Responsible for the execution of programming activities (development, quality control and
documentation) in support of clinical studies.
Principle Responsibilities:
1, Develop SAS programs and macros in support of clinical trial activities.
2, SDTM data review.
4, ADaM metadata and datasets creation.
5, Creating and validating the tables, listings, and figures
7, Drive programming activities to ensure quality and on-time deliverables.
9, Programming lead in a phase I or BE/BA study

Bachelor or Master degree in statistics, medical
statistics, clinical epidemiology, computer science,
mathematics or other scientific field (or equivalent
theoretical/technical depth).
0~2 years of experience in programming, preferably
in a global pharmaceutical/CRO company.
Knowledge of SAS programming language
Good in Oral and writing English

1、协助QCM进行内外内部项目QC;
2、确保公司SOP实施依从性及支持业务团队解决质量相关问题；
3、承担业务部门日常及其他部门培训需求；
4、培训及带教QC部门新员工；
5、QC部门其他管理及相关工作；

1、医药相关专业，本科及以上学历，临床医学或药学优先；
2、制药行业或CR0经验不少于4年，临床运营优先。
3、质量控制经验和/或培训不少于1年。

1. 评估方案和研究设计
2. 协调与申办方进行研究前的实地拜访、协助准备并提交伦理文件
3. 安排和准备监查访视，提前准备试验文件
4. 协助接受来自申办方的研究药物和物资清单
5. 确保样本的正确收集、处理和运输、确保设备维护的相关文件的齐全
6. 协助招募计划制定（例如，为招募计划获取审查、联系并安排日程）
7. 协助筛选潜在的受试者，以获得要求的药物史和相关的医疗记录、协助访视安排
8. 根据ICH-GCP以及SOP学习不良事件的定义及相关上报和记录流程、协助研究者收集和报告AE/SAE
9. 在研究访视中对研究方案所要求的数据进行收集和协助评估
10. 协助填写CRF、协助将数据输入EDC、根据需要确保研究数据的准确性和正确性
11. 完成医疗判断除外的数据质疑的解决并回复申办方
12. 提供研究者费和受试者交通补偿费的计算、发放和发票的收集

1. 护理/药学等医药相关背景（大专以上）
2. 0.5年以上CRC工作经验
3. 熟悉ICH-GCP和有关的法律法规要求
4. 英语听说读写良好
5. 熟练使用office软件（Word、Excel、PowerPoint等）
6. 良好的口头和书面沟通能力
7. 良好的团队合作精神，积极主动，注重细节
8. 良好的客户服务意识
9. 能够接受出差

1、完成申办方新产品立项有关的部分调研、评估工作；
2、制定注册项目的预算、计划、进度追踪和总结；
3、审核药械注册申报资料，并保证在规定时间内完成申报；
4. 负责申报过程中现场核查的协调准备工作；
5. 负责注册申报的后续资料提交及审评审批状况的跟踪；
6. 负责对临床试验及药械研发的全过程提供注册技术要求方面的支持；
7. 负责跟踪药械注册进度，及时获取药械注册信息，并根据需要对注册申请资料进行补充；
8. 维护与药监部门领导、专家及申办方的关系，树立良好的公司形象；
9. 及时获悉国家医药、注册和研发等政策、规章、改革信息和最新指导原则，并及时有效传达新法规及调整部门工作；搜集、整理国际药政法规、医药信息，及时向公司有关部门通告。

1、药学相关专业硕士及以上学历;
2、3年以上同岗位工作经验;
3、熟悉并掌握药械管理及注册等相关法规及技术指导原则，了解国家药械注册法规和指南;
4、熟悉药械注册申报流程和各个环节，熟悉申报资料的撰写及具有对申报资料审核的能力;
5、较强的药械注册信息检索和分析调研能力，良好的项目运作能力，具有解决问题的经验和思路;
6、具有强烈的责任心、较强沟通能力、独立工作能力、团队合作能力和学习能力。

1. 准备和参与项目竞标，必要时出席现场竞标会，并作现场演示
2. 带领项目团队根据ICH-GCP/GCP，适用的法规及SOP，监督CRC在研究中心实施和开展临床研究
3. 准备及实施项目相关的培训，参与内外部的沟通和相关演示
4. 参加及支持研究者会议，必要时参与演讲及演讲材料的准备
5. 审核CRC日常工作报告，指导/协助CRC解决项目执行中产生的问题
6. 管理项目预算，确保项目支出按照合同执行，或保持在可接受范围内
7. 解决CRC的困难和问题，为CRC提供支持，维护团队稳定
8. 必要时，适时指导和带教CRC
9. 必要时，指导和带教项目经理（仅适用于资深项目经理）
10. 协同公司其它部门，参与业务拓展和客户管理工作，推动公司整体业务发展

1. 护理/药学等医药相关背景（大专以上）
2. 2年以上CRC经验，1年以上项目管理经验
3. 熟悉临床试验流程
4. 熟悉有关的法律法规要求
5. 有效地管理及培训团队
6. 能够参与竞标并独立承担项目
7. 英语听说读写良好
8. 熟练使用office软件（Word、Excel、PowerPoint等）
9. 良好的口头和书面沟通能力
10. 良好的团队合作精神，积极主动
11. 良好的客户服务意识
12. 一定的解决问题能力
13. 能够接受出差
14. 能够严格保密

1. 组织招募项目竞标/制定新药临床试验受试者招募策略
2. I-IV期项目临床试验受试者招募
3. 收集信息，制定有效可行的行动计划
4. 组织参与临床研究相关学术活动
协助进行项目的可行性调研；
分析同期各研究中心同类项目执行情况；
完成直线经理分配的其他工作。

1. 3年以上新药临床试验受试者招募/管理经验
2. 医药/药学专业背景，自我学习能力强
3. 对新药临床研究领域感兴趣
4. 具有较强的沟通协调分析能力
5. 具有强烈的目标导向
6. 能接受每月一定的出差频率
7. 肿瘤项目受试者招募/管理经验优选考虑

1、负责公司临床试验项目的开展、管理并定期向申办方汇报项目进度；
2、根据项目组建团队、制定项目计划书、分析招募项目的难点、预估项目执行风险、对团队进行方案培训等一系列项目执行策略，确保项目组成员按照SOP、GCP及相关法律法规完成招募工作；
3、控制项目成本，负责项目的回款及财务信息的整理；
4、接受项目质控或稽查，确保项目质量；
5、根据商务要求参与调研和竞标；

任职要求
1、护理/临床医学/临床药理学/药学等相关专业本科及以上学历，英语CET4及以上，口语流利、读写熟练者优先；
2、临床试验行业CRC/CRA2年工作经验；有PM，APM、CRC/CRA Leader经历者优先；
3、熟悉GCP等临床试验相关法律法规；
4、沟通表达、协调能力良好，抗压能力强；

1. Ensure timely deliverable of an EDC (Electronic Data Capture) development group with high quality and compliance with industry guidelines, regulatory requirement, SOPs in clinical trials.
2. Streamline working process and improve efficiency.
3. Review or develop DM documents include but not limited eCRF, Edit Check Specification etc. following SOPs
4. EDC system development: eCRF design, Edit check development, system setting, report development etc.
5. EDC macro design and development
6. Be expert on at least one EDC platform, knowledge and experience on other platforms
7. Design, build and maintain metadata repository
8. Create and/or review related documents

1. Extensive experience in EDC development on at least one EDC platform. Medidata Rave is preferred.
2. Education: Bachelor or Master Degree in Computer Science, Biostatistics, Statistics, Epidemiology, Mathematics, or other scientific field (or equivalent theoretical/technical depth).
3. Programming Language like C#.
4. Good communication skill, project management and/or people management skill
5. Advanced clinical trial knowledge and good understanding on DM processes
6. Extensive knowledge of CDISC standards include but not limited to CDASH, SDTM, Define etc.
7. Excellent in Oral and writing English

1. Be responsible for the progress, deliverables and quality of Data Management (DM) work for one or more clinical trials with role of DM project manager.
2. Custom facing.
3. Collaborate with other functions either within the company or outside in the conduct of clinical trials, representing DM and provide strong DM expertise in study team.
4. Provide comprehensive DM guidance to study team as well as junior college. Be able to provide solutions to resolve issues. When needed, do DM hands-on work include but not limited to DMP, CRF design, CRF completion guideline, Edit check specification, medical coding, SAE reconciliation etc.
5. Compliance with GCP, regulations, company and/or sponsor SOPs. Ensure the inspection readiness of DM work.
6. May perform study lead role or people manager role.
7. May perform Subject Matter Expert role.

1. Experience of leading full scope of DM work throughout the study independently.
2. Comprehensive DM knowledge and experience.
3. Excellent project management, communication, multi-task management skills,
4. Experience and knowledge of EDC system, CDISC standards include but not limited to CDASH, SDTM, define etc..
5. Understand medical and pharmaceutical terms and have TA knowledge.
6. Education: Bachelor or Master Degree in Medicine, Pharmacology, Statistics, Mathematics and other medical or data management related majors.
7. Familiar with MS office; familiar with SAS software.
8. Work independently, good at learning, with a proactive attitude. Capable to work under pressure.
9. Excellent in Oral and writing English

1、根据各项目月度/季度入组计划，完成受试者的招募入组任务，熟悉受试者情况并能表现出项目专业的严谨性；
2、能够有效完成各项目季度入组计划，及时跟进筛查入组过程，全面记录受试者信息；
3、制定个人行动计划，能够有效拜访目标医院／科室／医生，建立受试者招募的合作关系；
4、掌握各项目必须的专业知识，通过入排标准，对受试者做出初步筛选甄别，提高筛选率；
5、根据项目招募情况，进行受试者的随访管理；
6、定时总结并反馈各项目的招募情况；
7、能够不断学习项目专业知识及完成公司领导临时交办的其他任务。

1. 1年以上医药销售经验
2. 医药/药学专业背景，自我学习能力强
3. 对新药临床研究领域感兴趣
4. 具有较强的沟通协调分析能力
5. 具有强烈的目标导向
6. 能接受每月一定的出差频率
7. 肿瘤医药销售经验优选考虑
8. 受试者招募经验优选考虑

1 Assist PV Director in maintaining the company pharmacovigilance system, operations, audit readiness and business continuity;
2 Collaborate with cross functional teams, stakeholders, partners or vendors, as directed by the PV Director, to ensure the PV procedure implemented well in each project and ensure the audit readiness, PV and regulatory compliance;
3 Provide PV oversight to each project;
4 Local PV SOP drafting and maintaining;
5 Manage safety reports, relevant data bases and/or trackers for PV compliance;
6 Provide training to related personnel, including PV duties and responsibilities, including proactive approach to safety case reporting and documentation;
7 Assist PV team to collaborate with other functions to ensure coordinated responses and case resolution;
8 Other safety work assigned by the PV Director

1、Bachelor degree or above, Major in Medicine or Life Science or health-related is preferred
2、5 or more years of relevant pharmaceutical or related experience (e.g. drug safety, clinical development, medical affairs)
3、Strong orientation towards cross-functional teamwork
4、Familiar with MedDRA and safety databases is preferred
5、Good verbal and written English communication skills
6、Experience using computerized systems (PC-Windows and MS Office)

• 设置供员工使用的电脑设备，正确安装操作系统和公司规定的软件
• 为操作系统、应用程序和软硬件相关问题提供技术支持
• 访问权限管理
• 与供应商合作，保持库存有序
• 处置IT资产并使其保持最新
• 直线经理分配的其他任务

• 全日制计算机或网络相关专业毕业；
• 至少1年以上的相关全职工作经验优先，也欢迎优秀的应届毕业生；
• 持有Linux类、微软类认证、阿里云或者亚马逊云认证优先；
• 有较好的英语阅读能力优先。

1. 根据临床前信息配合医学、统计学同事设计合理高效的I期试验；
2. 从临床药理角度充分解读I期的安全性、有效性、药物动力学数据，为II期试验的设计
提供临床药理的支持；
3. I-III期相关的临床药理相关部分试验设计、数据总结、报告撰写等；
4. 结合定量药理工具，对PK/PD/AE等数据进行解读；
5. 临床药理相关文档的中英文撰写，中英语的口头交流、报告等；
6. 负责对药物临床项目的临床、分析单位质量抽查或者根据公司需要进行项目自查；

1. 学位要求：硕士以上，博士优先
2. 专业要求：临床药理相关专业
3. 工作经验：在制药企业或 CRO 公司有相关工作经验，工作经验不少于 6 年
4. 能力要求：
（1） 具有较强的执行力；
（2） 具有较强的独立科研能力及逻辑思维能力；
（3） 具有清晰的书面和口头表达能力，善于进行活跃而积极的沟通；
（4） 具有较强的集体意识和良好的团队合作精神；
（5） 具有良好的问题协调/解决能力及应急处置能力；
（6） 具有良好的适应能力，能在时间限制和任务压力下工作；
（7） 在本行业有一定的人脉关系基础，具有良好的人际关系；
（8） 热爱并看好本行业，有良好的职业道德和奉献精神。
5. 技能要求：
（1） 熟悉《药品管理法》、《新药审批办法》，熟悉ICH-GCP，熟悉药物研发的全过
程，精通临床试验中生物分析的全过程，熟悉生物分析的发展与现状；
（2） 熟悉GLP及质量控制；
（3） 熟悉定量药理工具。
6. 其他要求：
（1） 人品端正，诚实可信；
（2） 身体与心理健康，热爱生活；
（3） 具有良好的企业形象意识。