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CRO:
赵小玲 Linda
简历投递:
xiaoling.zhao@bestudycro.com
SMO:
刘军霞 Ayuki
简历投递:
junxia.liu@bestudycro.com
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职位 发布时间 招聘人数 招聘地点 操作
Statistician Manager 2020/03/26 2 上海、成都、北京 展开
岗位职责:

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

任职要求:

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

SQC 2020/06/29 1 上海 展开
岗位职责:

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;

任职要求:

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。

Clinical Research Associate II 2020/03/26 5 广州、福州、济南、合肥 展开
岗位职责:

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

任职要求:

• 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

高级医学经理/副经理 2020/06/29 3 上海、北京 展开
岗位职责:

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。

任职要求:

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。

临床药理高级经理/副总监 2020/06/29 1 上海 展开
岗位职责:

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;

任职要求:

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。

注册高级经理/高级经理 2020/06/29 2 上海 展开
岗位职责:

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。

任职要求:

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。

临床数据管理经理 2020/06/29 1 上海、武汉、成都 展开
岗位职责:

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.

任职要求:

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

EDC建库经理 2020/06/29 1 上海、武汉、成都 展开
岗位职责:

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

任职要求:

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

SAS编程经理 2020/06/29 1 上海、武汉、成都 展开
岗位职责:

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

任职要求:

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

KA专员 2020/06/29 4 重庆、武汉、广州、郑州 展开
岗位职责:

Site管理,根据试验方案、合同规定的工作范围、SOP和GCP的要求通过与负责研究中心机构、伦理沟通解决项目启动访视前遇到的问题,建立良好的沟通方式,树立公司良好品牌形象;
客户关系管理,负责多个项目、研究中心研究者客户关系持续跟进维护;
参与研究中心临床试验协议的谈判与签署工作;
协助公司CRO团队同事完成研究中心启动所需核心文件的收集、审阅、批准等工作;
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。

任职要求:

大专及以上学历,医学药学专业;
医药销售经验1-3年或CRC、CRA;
性格外向,善于沟通协调,敏锐的洞察力;
能接受每月一定频率的出差;
主观能动性强,有一定的组织策划能力。

Senior Clinical Research Associate (SCRA) 2020/03/26 5 广州、济南、福州、合肥 展开
岗位职责:

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. Independent 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. Assist and/or support project manager/line managers regarding study site management
skills mentoring/coaching from site selection to study closeout, if applicable
14. Assist and/or support project manager regarding study team member training on the
protocol, protocol amendments, study procedures and/or company processes
15. Assist and/or acting as project manager regarding project management activities under
study requirements and/or company processes with appropriate guide or coaching in place
16. Participate in training and mentoring of new staff ensuring compliance with ICH/GCP,
company SOPs and/or company policies, if applicable
17. Assist and/or contribute to process improvements, knowledge transfer and best practice
sharing, if needed
18. Other works which line manager or company assigned

任职要求:

• 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
• At least 3 years or above clinical trial working experience in
CRO/Pharmaceutical company or equivalent experience
• Candidates with clinical research experience in multinational
pharmaceutical companies or multinational CROs was
preferred
Technical/skills Training
• Familiar with GCP and International Conference on Harmonization (ICH) guidelines
• Familiar with drug development related laws and regulations knowledge
• Basic knowledge with project management/people management or equivalent manager
level knowledge 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 Microsoft office software (Word, Excel, Power Point, etc) or equivalent
software familiar
Others
• Able to work at sites and frequently travel
• Good at varies kinds of excellent/effective communication skills
• Good organization and problem-solving ability, could independent to resolving and handling
site questions or issues
• Team-work spirit, ability to build and maintain efficient working relationships with colleagues,
managers and customers
• Self-motivated, could accept challenges and work under pressure

DM数据管理(经理/副经理/主管) 2020/03/26 1 上海、成都、武汉 展开
岗位职责:

1. Be responsible for the progress,deliverables and quality of Data Management (DM) work for one or more clinicaltrials with role of DM project manager.
2. Custom facing.
3. Collaborate with other functions eitherwithin the company or outside in the conduct of clinical trials, representingDM and provide strong DM expertise in study team.
4. Provide comprehensive DM guidance tostudy team as well as junior college. Be able to provide solutions to resolveissues. When needed, do DM hands-on work include but not limited to DMP, CRFdesign, CRF completion guideline, Edit check specification, medical coding, SAEreconciliation 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 peoplemanager role.
7. May perform Subject Matter Expert role.

任职要求:

1. Experience of leading full scope of DMwork throughout the study independently.
2. Comprehensive DM knowledge andexperience.
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 pharmaceuticalterms and have TA knowledge.
6. Education: Bachelor or Master Degree inMedicine, Pharmacology, Statistics, Mathematics and other medical or datamanagement related majors.
7. Familiar with MS office; familiar withSAS software.
8. Work independently, good at learning,with a proactive attitude. Capable to work under pressure.
9. Excellent in Oral and writing English

PV主管/经理 2020/03/26 1 上海 展开
岗位职责:

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

任职要求:

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)

财务副经理 2020/03/26 1 上海 展开
岗位职责:

1、制订公司财务、会计制度和预算管理制度,建立和完善财务管理和 会计核算体系;
2、负责公司内控制度建设、执行和公司内部审计工作;
3、负责公司日常财务核算,编报公司财务预算和决算,
4、分析公司的财务经营情况,参与公司的经营管理。
5、负责监督和指导内部其他工作岗位的相关工作.
6、负责公司资金调度和管理,根据公司资金运作情况, 合理调配资金, 确保公司资金正常运转。办理各类结算业务,办理银行帐户、办理公司纳税申报工作;
7、负责接受审计、稽核、税务和有关上级领导部门工作检查;
8、对公司经济业务的决策提出财务或税收筹划建议;

任职要求:

1. 财务审计工作
2. 报税及所得税清算工作
3. 工资制作及发放工作
4. 员工个税申报及管理工作
5. 应收账款、应付账款的管理工作
6. 资金日常管理工作
7. 财务部人员日常管理工作

地区经理 2020/03/26 2 上海、北京 展开
岗位职责:

1. 按照部门项目和发展规划,协助大区经理参与招聘和面试工作
2. 参与城市主管、CRC的绩效评估,加薪/升职/转岗/降职/劝退/辞退的处理
3. 根据区域内CRC的FTE,协调分配项目安排,保证项目需求
4. 协助安排区域内培训工作、带教工作
5. 组织区域内会议,传达公司决策
6. 围绕公司文化建设,组织相关团建活动,营造良好工作氛围,提高团队凝聚力
7. 及时解决CRC的困难和问题,为CRC提供支持,维护团队稳定
8. 配合项目组完成ASV
9. 配合公司其它部门,参与业务拓展和客户管理工作,推动公司整体业务发展
10. 参与项目竞标工作
11. 负责项目管理工作
12. 定期向大区经理汇报区域内情况

任职要求:

1. 护理/药学等医药相关背景(大专以上)
2. 3年以上CRC工作经验;1年以上CRC管理经验
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. 具有一定的创新意识,在团队里起积极正面的引导作用
6. 了解项目管理基础知识
7. 熟练使用office软件(Word、Excel、PowerPoint等)
8. 良好的口头和书面沟通能力
9. 良好的团队合作精神,积极主动
10. 良好的客户服务意识
11. 一定的解决问题能力
12. 能够接受出差
13. 能够严格保密

项目经理(SMO) 2020/03/26 5 广州、北京、上海、杭州、南京、武汉、成都等 展开
岗位职责:

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

任职要求:

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

Project Manager(CRO) 2020/03/26 3 北京、上海、广州 展开
岗位职责:

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

任职要求:

• 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

Senior CRC(高级临床研究协调员) 2020/03/26 若干 全国 展开
岗位职责:

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
13. 带领区域团队,与项目管理团队和申办方保持沟通
14. 在必要时为区域项目团队成员提供项目培训
15. 监督和管理区域项目CRC的临床试验现场活动,并组织相关培训

任职要求:

1. 护理/药学等医药相关背景(大专以上)
2. 2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. 具有一定的创新意识,在团队里起积极正面的引导作用
6. 了解项目管理基础知识
7. 熟练使用office软件(Word、Excel、PowerPoint等)
8. 良好的口头和书面沟通能力
9. 良好的团队合作精神,积极主动,注重细节
10. 良好的客户服务意识
11. 能够接受出差

Junior CRC(初级临床协调员) 2020/03/26 若干 全国 展开
岗位职责:

1. 学习ICH-GCP,公司GCP以及临床试验相关知识和内容
2. 在带教指导下,评估方案和研究设计
3. 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
4. 安排和准备监查访视,提前准备试验文件
5. 协助接受来自申办方的研究药物和物资清单
6. 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
7. 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)
8. 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
9. 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
10. 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
11. 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
12. 完成医疗判断除外的数据质疑的解决并回复申办方
13. 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

任职要求:

1. 护理/药学等医药相关背景(大专以上)
2. 应届生或无相关经验
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

CRC I(一级临床研究协调员) 2020/03/26 若干 全国 展开
岗位职责:

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

任职要求:

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

CRC II(二级临床研究协调员) 2020/03/26 若干 全国 展开
岗位职责:

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

任职要求:

1. 护理/药学等医药相关背景(大专以上)
2. 1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. 具有一定的创新意识,在团队里起积极正面的引导作用
6. 熟练使用office软件(Word、Excel、PowerPoint等)
7. 良好的口头和书面沟通能力
8. 良好的团队合作精神,积极主动,注重细节
9. 良好的客户服务意识
10. 能够接受出差

招聘专员 2020/03/26 1人 上海 展开
岗位职责:

1.全面负责公司内部的人才招聘。
2.根据现有编制及业务发展需求,协助上级确定招聘目标,汇总岗位需求数目和人员需求数目,制定并执行招聘计划。
3.调查公司所需人才的外部人力资源存量与分布状况,并进行有效分析,对招聘渠道实施规划、开发、维护、拓展,保证人才信息量大、层次丰富、质量高,确保招聘渠道能有效满足公司的用人需求。
4.发布职位需求信息,做好公司形象宣传。
5.搜集简历,对简历进行分类、筛选,安排人员应聘面试,确定面试名单,通知应聘者前来面试。
6.组织相关用人部门人员协助完成面试工作,确保面试工作的及时开展及考核结果符合岗位要求。
7.负责招聘广告的撰写,招聘网站的维护和更新,以及招聘网站的信息沟通。
8.招聘费用的申请、控制和报销。
9.总结招聘工作中存在的问题,提出优化招聘制度和流程的合理化建议,完成招聘分析报告。
10.负责建立企业人才储备库,做好简历管理与信息保密工作。
11.搜集各地区人才市场信息,并熟悉各地区人事法规。
12.与各地区劳动保障,人才,学校沟通联系,对应届毕业生实习学生的就业问题达成共识。
13.跟踪和搜集同行业人才动态,吸引优秀人才加盟公司。
14.熟悉公司人力资源制度,对应聘人员提出的相关问题进行解答。

任职要求:

1. 大专以上学历,人力资源、心理学、管理类相关专业。
2.2 年以上招聘工作经验,有医疗行业招聘工作经验优先。
3. 熟悉各种招聘渠道、招聘流程,有一定的面试技巧。

招聘主管 2020/03/26 1人 上海 展开
岗位职责:

1、主要负责部门的人才招聘。
2、根据现有编制及业务发展需求,协助上级确定招聘目标,汇总岗位需求数目和人员需求数目,制定并执行招聘计划;
3、协助部门及上级完成需求岗位的职务说明书;
4、调查公司所需人才的外部人力资源存量与分布状况,并进行有效分析,对招聘渠道实施规划、开发、维护、拓展,保证人才信息量大、层次丰富、质量高,确保招聘渠道能有效满足公司的用人需求;
5、总结招聘工作中存在的问题,提出优化招聘制度和流程的合理化建议,完成招聘分析报告;与其他招聘人员进行招聘流程、招聘方法与技巧的沟通和交流,提高招聘活动效率;
6、负责建立公司人才储备库,做好简历管理;
7、跟踪和搜集同行业人才动态,吸引优秀人才加盟公司;
8、招聘费用的申请、控制和报销;
9、根据部门的实际情况,规划员工职业发展,为人才梯队提供资源;
10、分析部门的人员绩效管理,跟进薪酬绩效等工作,提供建议及指导;
11、参与部门人员成长方面相关项目的实施、监督、评估,协助培养部门需求的人才,参与公司培训体系的搭建、完善与优化
12、领导交办的其他事宜。

任职要求:

1、对现代企业人力资源管理模式有系统的了解和实践经验积累,对人力资源管理招聘模块均有较深入的认识,能够指导该职能模块的工作;
2、具备现代人力资源管理理念和实操经验;
3、较强的激励、沟通、协调、团队领导能力;责任心、事业心强。

IT专员 2020/03/26 3 上海虹口 展开
岗位职责:

1、负责公司的Domain、VPN、内外网的管理;
2、协调外部供应商,负责公司电脑软硬件及办公电子设备(如:复印机、传真机、打印机及会议室多媒体设备、门禁系统等)的维护及台账工作;
3、负责病毒的查杀,内部信息系统建设、处理网络及计算机故障,维护网络系统安全;
4、管理优化和维护公司Ticket\ERP\ BI\Email等系统,及时发现并修正存在问题,确保公司工作的正常;
5、负责对员工电脑知识方面的培训;
6、配合部门领导完成公司其他临时事宜;

任职要求:

1、3年及以上工作经验,计算机相关专业毕业;
2、精通电脑,熟悉IT软硬件的市场行情及一定的甄别能力;
3、熟悉制药、医疗、临床研究等领域的IT运维管理;
4、良好的团队意识、用户服务意识和沟通能力;
5、责任心强,具备不断学习的能力;
6、必须持有MCSE证书;持有ITIL\CCNA或CCNP更佳;
7、良好的英语阅读能力。

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