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CRO:
趙小玲 Linda
簡歷投遞:
xiaoling.zhao@bestudycro.com
SMO:
劉軍霞 Ayuki
簡歷投遞:
junxia.liu@bestudycro.com
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職位 發布時間 招聘人數 招聘地點 操作
科學統計師 2020/8/31 1 上海 展開
崗位職責:

職位描述:
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

任職要求:

職位要求:
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

Statistician Manager 2020/03/26 2 上海、成都、北京 展開
崗位職責:

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

任職要求:

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

Statistical Programmer Manager 2020/11/25 1 北京、廣州、上海、武漢、成都 展開
崗位職責:

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

任職要求:

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

SQC 2020/06/29 1 上海 展開
崗位職責:

1、協助QCM進行內外內部項目QC;
2、確保公司SOP實施依從性及支持業務團隊解決質量相關問題;
3、承擔業務部門日常及其他部門培訓需求;
4、培訓及帶教QC部門新員工;
5、QC部門其他管理及相關工作;

任職要求:

1、醫藥相關專業,本科及以上學歷,臨床醫學或藥學優先;
2、制藥行業或CR0經驗不少于4年,臨床運營優先。
3、質量控制經驗和/或培訓不少于1年。

資源管理經理 2020/11/18 1 上海 展開
崗位職責:

工作目的
1、統籌核對SMO所有人員工時,工時管理規范化、統一化。
2、培訓和培養各大區工時管理人員,提升大區內工時管理水平。
工作職責
1、根據工時管理規則,每月核對所有員工的FTE情況;
2、與大區經理對接FTE使用情況,針對超出規則或有異議的地方進行確認;
3、分析和總結SMO全員FTE情況,每月底出具相應報告給到總監及各大區經理;
4、培訓和培養各大區FTE管理人員,提升部門內FTE填寫質量,保證數據可靠;
5、與HR對接每月招聘信息,及時跟進SMO部門HC情況;
6、優化SMO部門工時管理流程;
7、定期向總監匯報,并協助總監完成交代的其他工作內容。

任職要求:

學歷:大專及以上學歷
專業:專業不限
有過3年以上臨床試驗工作經驗,熟悉工時管理內容
專業知識/技能
熟悉臨床試驗工時管理規則
計算機知識
熟練使用office軟件(Word、Excel、PowerPoint等)
其他
責任心強,關注細節,積極主動,溝通能力佳,反應靈活,邏輯清晰,對數字敏感,分析和總結能力強

Clinical Research Associate II 2020/11/25 5 上海、杭州、成都、濟南、鄭州 展開
崗位職責:

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

任職要求:

? 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

高級醫學經理/副經理 2020/06/29 3 上海、北京 展開
崗位職責:

1. 參與臨床項目競標,分析醫學研究策略,制定臨床研究開發計劃
2. 全面負責臨床研究項目的醫學工作
2.1. 臨床試驗相關材料的撰寫和翻譯,如臨床研究方案、研究者手冊(IB)、臨床研究綜述、臨床研究報告等。
2.2. 與注冊及臨床運營團隊合作,根據臨床試驗項目的關鍵時間節點完成注冊相關醫學材料的準備和遞交
2.3. 配合注冊團隊,與臨床研究監管機構的溝通和交流,對其提出的問題做專業的回復和解答。
2.4. 協助相關部門執行臨床試驗啟動、預算控制、電子數據表格的制作、數據質量管理。
2.5. 對臨床試驗進行過程中的數據、方案違背(PD)、不良事件(AE)等進行醫學審核。
2.6. 對CRA和研究中心提供醫學支持,及時回答提出的醫學問題,并做好整理和記錄。
2.7. 與相關領域的專家討論研究方案和相關專業問題,參與AB會
2.8. 醫學研究論文的撰寫、審校和投稿。
3. 文獻檢索與解讀,向內部人員或客戶提供最新的疾病和產品知識。
4. 協助制定和優化醫學部工作SOP、WI和QD;自覺與質控、數據管理、統計和SMO等部門建立良好合作,必要時協助制定部門間合作工作流程,不斷提升工作效率。
5. 招募并發展團隊,設定、管理團隊目標;向內部同事提供醫學知識培訓和研究方案培訓,必要時進行外部培訓。
6. 參與其它醫學相關工作。

任職要求:

1. 學歷:醫學或醫學相關專業,碩士或以上學歷。
2. 至少5年以上制藥行業或CRO公司醫學研究、醫學項目管理或醫學寫作工作經驗,至少一個完整的臨床研究項目經驗。
3. 具有較強的自我學習能力、良好的邏輯思維能力和獨立開展工作的能力。
4. 熟悉ICH-GCP,對中國醫藥政策法規有一定的了解。
5. 熟練操作電腦和醫學寫作常用的辦公軟件,如Adobe Acrobat、圖像處理軟件、Microsoft Office (Word/Excel/Powerpoint)、文獻管理軟件、Graphpad Prism等。
6. 良好的英語聽說讀寫譯能力,聽說能力應達到基本溝通的水平。
7. 良好的組織協調、人際關系溝通能力。
8. 良好的分析、計劃、執行能力。

臨床藥理高級經理/副總監 2020/06/29 1 上海 展開
崗位職責:

1. 根據臨床前信息配合醫學、統計學同事設計合理高效的I期試驗;
2. 從臨床藥理角度充分解讀I期的安全性、有效性、藥物動力學數據,為II期試驗的設計
提供臨床藥理的支持;
3. I-III期相關的臨床藥理相關部分試驗設計、數據總結、報告撰寫等;
4. 結合定量藥理工具,對PK/PD/AE等數據進行解讀;
5. 臨床藥理相關文檔的中英文撰寫,中英語的口頭交流、報告等;
6. 負責對藥物臨床項目的臨床、分析單位質量抽查或者根據公司需要進行項目自查;

任職要求:

1. 學位要求:碩士以上,博士優先
2. 專業要求:臨床藥理相關專業
3. 工作經驗:在制藥企業或 CRO 公司有相關工作經驗,工作經驗不少于 6 年
4. 能力要求:
(1) 具有較強的執行力;
(2) 具有較強的獨立科研能力及邏輯思維能力;
(3) 具有清晰的書面和口頭表達能力,善于進行活躍而積極的溝通;
(4) 具有較強的集體意識和良好的團隊合作精神;
(5) 具有良好的問題協調/解決能力及應急處置能力;
(6) 具有良好的適應能力,能在時間限制和任務壓力下工作;
(7) 在本行業有一定的人脈關系基礎,具有良好的人際關系;
(8) 熱愛并看好本行業,有良好的職業道德和奉獻精神。
5. 技能要求:
(1) 熟悉《藥品管理法》、《新藥審批辦法》,熟悉ICH-GCP,熟悉藥物研發的全過
程,精通臨床試驗中生物分析的全過程,熟悉生物分析的發展與現狀;
(2) 熟悉GLP及質量控制;
(3) 熟悉定量藥理工具。
6. 其他要求:
(1) 人品端正,誠實可信;
(2) 身體與心理健康,熱愛生活;
(3) 具有良好的企業形象意識。

注冊高級經理/高級經理 2020/06/29 2 上海 展開
崗位職責:

1、完成申辦方新產品立項有關的部分調研、評估工作;
2、制定注冊項目的預算、計劃、進度追蹤和總結;
3、審核藥械注冊申報資料,并保證在規定時間內完成申報;
4. 負責申報過程中現場核查的協調準備工作;
5. 負責注冊申報的后續資料提交及審評審批狀況的跟蹤;
6. 負責對臨床試驗及藥械研發的全過程提供注冊技術要求方面的支持;
7. 負責跟蹤藥械注冊進度,及時獲取藥械注冊信息,并根據需要對注冊申請資料進行補充;
8. 維護與藥監部門領導、專家及申辦方的關系,樹立良好的公司形象;
9. 及時獲悉國家醫藥、注冊和研發等政策、規章、改革信息和最新指導原則,并及時有效傳達新法規及調整部門工作;搜集、整理國際藥政法規、醫藥信息,及時向公司有關部門通告。

任職要求:

1、藥學相關專業碩士及以上學歷;
2、3年以上同崗位工作經驗;
3、熟悉并掌握藥械管理及注冊等相關法規及技術指導原則,了解國家藥械注冊法規和指南;
4、熟悉藥械注冊申報流程和各個環節,熟悉申報資料的撰寫及具有對申報資料審核的能力;
5、較強的藥械注冊信息檢索和分析調研能力,良好的項目運作能力,具有解決問題的經驗和思路;
6、具有強烈的責任心、較強溝通能力、獨立工作能力、團隊合作能力和學習能力。

臨床數據管理經理 2020/06/29 1 上海、武漢、成都 展開
崗位職責:

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.

任職要求:

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建庫經理 2020/06/29 1 上海、武漢、成都 展開
崗位職責:

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

任職要求:

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編程經理 2020/06/29 1 上海、武漢、成都 展開
崗位職責:

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

任職要求:

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

Statistical Programmer 2020/11/25 3 上海、北京、武漢、成都、廣州 展開
崗位職責:

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

任職要求:

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

KA專員 2020/06/29 4 重慶、武漢、廣州、鄭州 展開
崗位職責:

Site管理,根據試驗方案、合同規定的工作范圍、SOP和GCP的要求通過與負責研究中心機構、倫理溝通解決項目啟動訪視前遇到的問題,建立良好的溝通方式,樹立公司良好品牌形象;
客戶關系管理,負責多個項目、研究中心研究者客戶關系持續跟進維護;
參與研究中心臨床試驗協議的談判與簽署工作;
協助公司CRO團隊同事完成研究中心啟動所需核心文件的收集、審閱、批準等工作;
協助進行項目的可行性調研;
分析同期各研究中心同類項目執行情況;
完成直線經理分配的其他工作。

任職要求:

大專及以上學歷,醫學藥學專業;
醫藥銷售經驗1-3年或CRC、CRA;
性格外向,善于溝通協調,敏銳的洞察力;
能接受每月一定頻率的出差;
主觀能動性強,有一定的組織策劃能力。

Senior Clinical Research Associate (SCRA) 2020/11/25 5 上海、杭州、鄭州、濟南、成都 展開
崗位職責:

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

任職要求:

? 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數據管理(經理/副經理/主管) 2020/03/26 1 上海、成都、武漢 展開
崗位職責:

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.

任職要求:

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/經理 2020/03/26 1 上海 展開
崗位職責:

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

任職要求:

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)

財務副經理 2020/03/26 1 上海 展開
崗位職責:

1、制訂公司財務、會計制度和預算管理制度,建立和完善財務管理和 會計核算體系;
2、負責公司內控制度建設、執行和公司內部審計工作;
3、負責公司日常財務核算,編報公司財務預算和決算,
4、分析公司的財務經營情況,參與公司的經營管理。
5、負責監督和指導內部其他工作崗位的相關工作.
6、負責公司資金調度和管理,根據公司資金運作情況, 合理調配資金, 確保公司資金正常運轉。辦理各類結算業務,辦理銀行帳戶、辦理公司納稅申報工作;
7、負責接受審計、稽核、稅務和有關上級領導部門工作檢查;
8、對公司經濟業務的決策提出財務或稅收籌劃建議;

任職要求:

1. 財務審計工作
2. 報稅及所得稅清算工作
3. 工資制作及發放工作
4. 員工個稅申報及管理工作
5. 應收賬款、應付賬款的管理工作
6. 資金日常管理工作
7. 財務部人員日常管理工作

項目經理(SMO) 2020/03/26 5 廣州、北京、上海、杭州、南京、武漢、成都等 展開
崗位職責:

1. 準備和參與項目競標,必要時出席現場競標會,并作現場演示
2. 帶領項目團隊根據ICH-GCP/GCP,適用的法規及SOP,監督CRC在研究中心實施和開展臨床研究
3. 準備及實施項目相關的培訓,參與內外部的溝通和相關演示
4. 參加及支持研究者會議,必要時參與演講及演講材料的準備
5. 審核CRC日常工作報告,指導/協助CRC解決項目執行中產生的問題
6. 管理項目預算,確保項目支出按照合同執行,或保持在可接受范圍內
7. 解決CRC的困難和問題,為CRC提供支持,維護團隊穩定
8. 必要時,適時指導和帶教CRC
9. 必要時,指導和帶教項目經理(僅適用于資深項目經理)
10. 協同公司其它部門,參與業務拓展和客戶管理工作,推動公司整體業務發展

任職要求:

1. 護理/藥學等醫藥相關背景(大專以上)
2. 2年以上CRC經驗,1年以上項目管理經驗
3. 熟悉臨床試驗流程
4. 熟悉有關的法律法規要求
5. 有效地管理及培訓團隊
6. 能夠參與競標并獨立承擔項目
7. 英語聽說讀寫良好
8. 熟練使用office軟件(Word、Excel、PowerPoint等)
9. 良好的口頭和書面溝通能力
10. 良好的團隊合作精神,積極主動
11. 良好的客戶服務意識
12. 一定的解決問題能力
13. 能夠接受出差
14. 能夠嚴格保密

Project Manager(CRO) 2020/03/26 3 北京、上海、廣州 展開
崗位職責:

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

任職要求:

? 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(高級臨床研究協調員) 2020/03/26 若干 全國 展開
崗位職責:

1. 評估方案和研究設計
2. 協調與申辦方進行研究前的實地拜訪、協助準備并提交倫理文件
3. 安排和準備監查訪視,提前準備試驗文件
4. 協助接受來自申辦方的研究藥物和物資清單
5. 確保樣本的正確收集、處理和運輸;確保設備維護的相關文件的齊全
6. 協助招募計劃制定(例如,為招募計劃獲取審查、聯系并安排日程)
7. 協助篩選潛在的受試者,以獲得要求的藥物史和相關的醫療記錄、協助訪視安排
8. 根據ICH-GCP以及SOP學習不良事件的定義及相關上報和記錄流程、協助研究者收集和報告AE/SAE
9. 在研究訪視中對研究方案所要求的數據進行收集和協助評估
10. 協助填寫CRF、協助將數據輸入EDC、根據需要確保研究數據的準確性和正確性
11. 完成醫療判斷除外的數據質疑的解決并回復申辦方
12. 提供研究者費和受試者交通補償費的計算、發放和發票的收集
13. 帶領區域團隊,與項目管理團隊和申辦方保持溝通
14. 在必要時為區域項目團隊成員提供項目培訓
15. 監督和管理區域項目CRC的臨床試驗現場活動,并組織相關培訓

任職要求:

1. 護理/藥學等醫藥相關背景(大專以上)
2. 2年以上CRC工作經驗
3. 熟悉ICH-GCP和有關的法律法規要求
4. 英語聽說讀寫良好
5. 具有一定的創新意識,在團隊里起積極正面的引導作用
6. 了解項目管理基礎知識
7. 熟練使用office軟件(Word、Excel、PowerPoint等)
8. 良好的口頭和書面溝通能力
9. 良好的團隊合作精神,積極主動,注重細節
10. 良好的客戶服務意識
11. 能夠接受出差

Junior CRC(初級臨床協調員) 2020/03/26 若干 全國 展開
崗位職責:

1. 學習ICH-GCP,公司GCP以及臨床試驗相關知識和內容
2. 在帶教指導下,評估方案和研究設計
3. 協調與申辦方進行研究前的實地拜訪、協助準備并提交倫理文件
4. 安排和準備監查訪視,提前準備試驗文件
5. 協助接受來自申辦方的研究藥物和物資清單
6. 確保樣本的正確收集、處理和運輸、確保設備維護的相關文件的齊全
7. 協助招募計劃制定(例如,為招募計劃獲取審查、聯系并安排日程)
8. 協助篩選潛在的受試者,以獲得要求的藥物史和相關的醫療記錄、協助訪視安排
9. 根據ICH-GCP以及SOP學習不良事件的定義及相關上報和記錄流程
10. 在研究訪視中對研究方案所要求的數據進行收集和協助評估
11. 協助填寫CRF、協助將數據輸入EDC、根據需要確保研究數據的準確性和正確性
12. 完成醫療判斷除外的數據質疑的解決并回復申辦方
13. 提供研究者費和受試者交通補償費的計算、發放和發票的收集

任職要求:

1. 護理/藥學等醫藥相關背景(大專以上)
2. 應屆生或無相關經驗
3. 熟悉ICH-GCP和有關的法律法規要求
4. 英語聽說讀寫良好
5. 熟練使用office軟件(Word、Excel、PowerPoint等)
6. 良好的口頭和書面溝通能力
7. 良好的團隊合作精神,積極主動,注重細節
8. 良好的客戶服務意識
9. 能夠接受出差

CRC I(一級臨床研究協調員) 2020/03/26 若干 全國 展開
崗位職責:

1. 評估方案和研究設計
2. 協調與申辦方進行研究前的實地拜訪、協助準備并提交倫理文件
3. 安排和準備監查訪視,提前準備試驗文件
4. 協助接受來自申辦方的研究藥物和物資清單
5. 確保樣本的正確收集、處理和運輸、確保設備維護的相關文件的齊全
6. 協助招募計劃制定(例如,為招募計劃獲取審查、聯系并安排日程)
7. 協助篩選潛在的受試者,以獲得要求的藥物史和相關的醫療記錄、協助訪視安排
8. 根據ICH-GCP以及SOP學習不良事件的定義及相關上報和記錄流程、協助研究者收集和報告AE/SAE
9. 在研究訪視中對研究方案所要求的數據進行收集和協助評估
10. 協助填寫CRF、協助將數據輸入EDC、根據需要確保研究數據的準確性和正確性
11. 完成醫療判斷除外的數據質疑的解決并回復申辦方
12. 提供研究者費和受試者交通補償費的計算、發放和發票的收集

任職要求:

1. 護理/藥學等醫藥相關背景(大專以上)
2. 0.5年以上CRC工作經驗
3. 熟悉ICH-GCP和有關的法律法規要求
4. 英語聽說讀寫良好
5. 熟練使用office軟件(Word、Excel、PowerPoint等)
6. 良好的口頭和書面溝通能力
7. 良好的團隊合作精神,積極主動,注重細節
8. 良好的客戶服務意識
9. 能夠接受出差

CRC II(二級臨床研究協調員) 2020/03/26 若干 全國 展開
崗位職責:

1. 評估方案和研究設計
2. 協調與申辦方進行研究前的實地拜訪、協助準備并提交倫理文件
3. 安排和準備監查訪視,提前準備試驗文件
4. 協助接受來自申辦方的研究藥物和物資清單
5. 確保樣本的正確收集、處理和運輸;確保設備維護的相關文件的齊全
6. 協助招募計劃制定(例如,為招募計劃獲取審查、聯系并安排日程)
7. 協助篩選潛在的受試者,以獲得要求的藥物史和相關的醫療記錄、協助訪視安排
8. 根據ICH-GCP以及SOP學習不良事件的定義及相關上報和記錄流程、協助研究者收集和報告AE/SAE
9. 在研究訪視中對研究方案所要求的數據進行收集和協助評估
10. 協助填寫CRF、協助將數據輸入EDC、根據需要確保研究數據的準確性和正確性
11. 完成醫療判斷除外的數據質疑的解決并回復申辦方
12. 提供研究者費和受試者交通補償費的計算、發放和發票的收集

任職要求:

1. 護理/藥學等醫藥相關背景(大專以上)
2. 1年以上CRC工作經驗
3. 熟悉ICH-GCP和有關的法律法規要求
4. 英語聽說讀寫良好
5. 具有一定的創新意識,在團隊里起積極正面的引導作用
6. 熟練使用office軟件(Word、Excel、PowerPoint等)
7. 良好的口頭和書面溝通能力
8. 良好的團隊合作精神,積極主動,注重細節
9. 良好的客戶服務意識
10. 能夠接受出差

招聘專員 2020/03/26 1人 上海 展開
崗位職責:

1.全面負責公司內部的人才招聘。
2.根據現有編制及業務發展需求,協助上級確定招聘目標,匯總崗位需求數目和人員需求數目,制定并執行招聘計劃。
3.調查公司所需人才的外部人力資源存量與分布狀況,并進行有效分析,對招聘渠道實施規劃、開發、維護、拓展,保證人才信息量大、層次豐富、質量高,確保招聘渠道能有效滿足公司的用人需求。
4.發布職位需求信息,做好公司形象宣傳。
5.搜集簡歷,對簡歷進行分類、篩選,安排人員應聘面試,確定面試名單,通知應聘者前來面試。
6.組織相關用人部門人員協助完成面試工作,確保面試工作的及時開展及考核結果符合崗位要求。
7.負責招聘廣告的撰寫,招聘網站的維護和更新,以及招聘網站的信息溝通。
8.招聘費用的申請、控制和報銷。
9.總結招聘工作中存在的問題,提出優化招聘制度和流程的合理化建議,完成招聘分析報告。
10.負責建立企業人才儲備庫,做好簡歷管理與信息保密工作。
11.搜集各地區人才市場信息,并熟悉各地區人事法規。
12.與各地區勞動保障,人才,學校溝通聯系,對應屆畢業生實習學生的就業問題達成共識。
13.跟蹤和搜集同行業人才動態,吸引優秀人才加盟公司。
14.熟悉公司人力資源制度,對應聘人員提出的相關問題進行解答。

任職要求:

1. 大專以上學歷,人力資源、心理學、管理類相關專業。
2.2 年以上招聘工作經驗,有醫療行業招聘工作經驗優先。
3. 熟悉各種招聘渠道、招聘流程,有一定的面試技巧。

招聘主管 2020/03/26 1人 上海 展開
崗位職責:

1、主要負責部門的人才招聘。
2、根據現有編制及業務發展需求,協助上級確定招聘目標,匯總崗位需求數目和人員需求數目,制定并執行招聘計劃;
3、協助部門及上級完成需求崗位的職務說明書;
4、調查公司所需人才的外部人力資源存量與分布狀況,并進行有效分析,對招聘渠道實施規劃、開發、維護、拓展,保證人才信息量大、層次豐富、質量高,確保招聘渠道能有效滿足公司的用人需求;
5、總結招聘工作中存在的問題,提出優化招聘制度和流程的合理化建議,完成招聘分析報告;與其他招聘人員進行招聘流程、招聘方法與技巧的溝通和交流,提高招聘活動效率;
6、負責建立公司人才儲備庫,做好簡歷管理;
7、跟蹤和搜集同行業人才動態,吸引優秀人才加盟公司;
8、招聘費用的申請、控制和報銷;
9、根據部門的實際情況,規劃員工職業發展,為人才梯隊提供資源;
10、分析部門的人員績效管理,跟進薪酬績效等工作,提供建議及指導;
11、參與部門人員成長方面相關項目的實施、監督、評估,協助培養部門需求的人才,參與公司培訓體系的搭建、完善與優化
12、領導交辦的其他事宜。

任職要求:

1、對現代企業人力資源管理模式有系統的了解和實踐經驗積累,對人力資源管理招聘模塊均有較深入的認識,能夠指導該職能模塊的工作;
2、具備現代人力資源管理理念和實操經驗;
3、較強的激勵、溝通、協調、團隊領導能力;責任心、事業心強。

IT專員 2020/03/26 3 上海虹口 展開
崗位職責:

1、負責公司的Domain、VPN、內外網的管理;
2、協調外部供應商,負責公司電腦軟硬件及辦公電子設備(如:復印機、傳真機、打印機及會議室多媒體設備、門禁系統等)的維護及臺賬工作;
3、負責病毒的查殺,內部信息系統建設、處理網絡及計算機故障,維護網絡系統安全;
4、管理優化和維護公司Ticket\ERP\ BI\Email等系統,及時發現并修正存在問題,確保公司工作的正常;
5、負責對員工電腦知識方面的培訓;
6、配合部門領導完成公司其他臨時事宜;

任職要求:

1、3年及以上工作經驗,計算機相關專業畢業;
2、精通電腦,熟悉IT軟硬件的市場行情及一定的甄別能力;
3、熟悉制藥、醫療、臨床研究等領域的IT運維管理;
4、良好的團隊意識、用戶服務意識和溝通能力;
5、責任心強,具備不斷學習的能力;
6、必須持有MCSE證書;持有ITIL\CCNA或CCNP更佳;
7、良好的英語閱讀能力。

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