• 电话: +86 21 63862192
  • 邮箱: info@alphabiopharma.com
  • 上海: 黄浦区太仓路233号新茂大厦504-508室
  • 北京: 朝阳区光华路9号世贸商业中心4号楼天阶大厦2512室

人才理念

组织能力指的是团队整体发挥的战斗力

  • 深植于组织内部
而非个人,有可持续性

    深植于组织内部
    而非个人,有可持续性

  • 为客户创造价值

    为客户创造价值

  • 明显超越竞争对手

    明显超越竞争对手

组织能力要聚焦,优秀的公司往往在两三个方面展示出众所周知的组织能力;组织能力还要清晰界定,这样团队才能集中精力和资源来关注、开发这样的能力。

  • 员工思维

    员工思维

    员工是否展现与组织能力匹配的价值观、 行为和投入度?

  • 员工能力

    员工能力

    员工是否具备组织能力行为和投入度?

  • 员工治理

    员工治理

    公司是否提供有效的管理支持和资源容许员工充分发挥所长?

打造组织能力的三个维度

打造组织能力的三个维度,必须符合两个原则:
一是平衡,即三个能力要一样强;
二是匹配,三个支柱的重点必须与所需的组织能力协调。
打造组织能力的三个维度

员工风采

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icon
ICON

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员工发展与培训

  • 新员工培训

    新员工培训
  • 通用管理技能培训

    通用管理技能培训
  • 专业技能培训

    专业技能培训

培训方式

  • 现场培训现场培训
  • 在线直播课程在线直播课程
  • 午餐分享会午餐分享会
  • 线下培训沙龙
线下培训沙龙

员工福利

  • 福利年假
    福利年假
  • 带薪病假
    带薪病假
  • 商业保险
    商业保险
  • 年度旅游
    年度旅游
  • 年度体检
    年度体检
  • 生日会
    生日会
  • 下午茶
    下午茶
  • 节日福利
    节日福利
  • 团队建设
    团队建设
  • 员工班车#
    员工班车
  • 员工住宿#
    员工住宿
  • 福利午餐#
    福利午餐

出现icon为工厂员工专享福利

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招聘信息

高级质量保证经理 (GCP)

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders (e.g. Clinical Operations, PV), and interacts with various teams to ensure corrective and preventative actions are taken to bring audit observations to closure as applicable. Activities may include routine and directed audits of investigator sites, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities.
Perform risk assessment and evaluate in area of responsibility.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QMS assessments and to support the implementation of associated risk mitigation strategies.
Supports the development of SOPs to ensure alignment with local laws and regulations.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools.
Conduct the pre-qualificatioin audit to the potential vendors if required and provide the recommendations to the business for the vendor assessment and selection.
Provides input into Quality Agreement(s) signed with vendors as appropriate.
Actively involved/leading pre-inspection preparation activities in collaboration with business customers/partners.
Prepares and educates internal and external business customers/partners (incl investigator site staff) on inspection management.
Hosts and /or participates in inspection(s).
Responsible for inspection response management and tracking through resolution.
Actively participates in lessons learnt/shared learning.
To provide GCP and/or GVP compliance interpretation, consultation, training. Act as a subject matter expert to respond to GCP and/or GVP compliance inquiries.

任职要求

Bachelor's Degree or equivalent in scientific or health related area.
A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least2~3 years of previous Quality related experience. Experience in conducting a broad range of audits is preferred.
Knowledge of ICH guidance, China local regulations, new drug regulations and current industry practice.
Knowledge of Quality Management Systems principles, including policies, procedures and processes.
Knowledge of clinical research operation and/or Pharmacovigilance and its QMS.
Proficient written and spoken English language skills.
Knowledge of drug development process.
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临床监察员

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:多人
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岗位描述

• Pre-Study/Start up Site Management Activities
-- Identify potential sites, investigators and site staff;
-- Establish site-level recruitment strategy/plan
-- Ensure required documents, e.g. subject informed consent(s) and protocol, are approved by the applicable local Ethics Committee(s)
-- Ensure all required study start-up documentation and supplies (drug and non-drug) is in place and the site is able to start on time and according to plan
-- Establish investigator file and submit essential documents to trial master file
-- Ensure adequate contract is signed and payment is defrayed according to contract
-- Ensure timely site initiation in line with project timeline
-- Build and maintain positive relationships with the site and investigators
-- Create site information in CTMS and project tracking tools on site level
-- Complete timely reports/correspondence to record issue, action plan and resolution

• Study conduct site monitoring activities.
-- Complete site recruitment according to recruitment strategy/plan
-- Carries out monitoring activities, on-site visits or remote communication, in line with monitoring plan, ensuring adherence to protocol and study procedure, ICH - GCP guidelines and local regulations.
-- Perform SDV during on-site monitoring visits according to the protocol SDV plan
-- Perform site-level drug accountability (ensuring proper handling, storage, administration, record-keeping and disposition) and emergency codes check
-- Verify storage and shipment of biological samples and other protocol specific diagnostics requirement
-- Maintain and update investigator file, submit essential documents to trial master file
-- Verify timely, complete and accurate reporting of SAE/Pregnancy Forms. Ensure site receives all safety information and submits these reports, as appropriate, to the local ethics committee/Health Authorities
-- Submit update study information (e.g. protocol, subject informed consent form, regular study progress report) to the applicable local Ethics Committee(s) and get approval within time frame
-- Update site information in CTMS and project tracking tools on site level
-- Complete timely reports/correspondence to record issue, action plan and resolution
-- Ensure timely and accurate payment to site according to contract and progress

•Conducts Study Site Close-Out Activities.
-- Ensure proper return and disposition of all study-related supplies and equipment
-- Notify site and EC of the completion of the study and submit study reports as requested
-- Ensure site information in CTMS and project tracking tools is complete
-- Ensure site reports and correspondence is complete
--Complete audit finding solution, if the study is registration study, CRA need to do the CFDI inspection readiness preparation and handle the site inspection activities.

• Project Management Activities (As the senior CRA)
--Partial working time could be spent on small-scale clinical trials management activities refer to CPM’s Job Responsibilities as requested under line manager’s support, as a part of achieving personal development in the CRA position.
--In one study, support PM to do the part working of project management as the lead CRA.

任职要求

• Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse , BPharm)
• At least 1-2 years (CRA level) clinical operation monitor experience for senior position.
• Good knowledge in GCP for senior position
• Good command of written and verbal English
• Good communication and organization skills
• Good and proactive working attitude
• Value importance of teamwork
• Ability to work independently
• Experience in oncology study is preferred
• Travel needed
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临床项目经理/高级经理

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

• Project planning—Create a project team, communicate final protocol and explain scientific approach/performance to the team (e.g. cost, time, quality).
• Project Monitoring and Guiding—Monitor/evaluate/review the scientific performance of the study.
• Project Problem Management—Suggest solutions and actions to solve study problems, manage the impact on time and cost, review protocol changes.
• Learn Process—Perform scientific mentoring activities (e.g. training study specific techniques, assisting with complex analytical work/problem solving). Participate in post project assessment by providing input on team performance (accomplishments and glitches). Responsible for the design, conduct and reporting of studies to meet scientific, regulatory requirement.
• Initiate a long-range planning and technical policies of the department
• Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and timeline, and for managing the clinical portion of the study budget.
• Responsible in resource allocation, task oversight and delegation, development of monitoring plans, contingency planning, and management of communications and reporting.
• Lead in preparation and delivery of study documents for example SDV plan, study management plan for deliverables, confidentiality agreement and clinical trial applications.
• Provide clinical monitoring expertise and leadership for large, complex protocols and/or international programs
• Lead and motivate the clinical team. Act as a mentor and train CRA in the responsibilities of the position
• Promote effective teamwork among project team members
• Provide performance evaluation and feedback of team members
• Work independently and to effectively prioritize tasks, actively seek input, problems solve and work within a matrix team environment
• Effective verbal and written communication skills. Highly effective interpersonal and organization skills. Effective presentation skills, is able to prepare a presentation for an investigators meeting.
• Coordinate operational aspects of study and lead and participate in activities and ensure quality, consistency, and integration of study data and progress deliverables to time cost and quality from study concept through database lock and study close-out activities.
• Provide input into non-project work, training activities, and development of procedure as needed.
• Manage external service provider.
• Help in the development and implementation of plans associated with audits and regulatory inspections.
• Planning and conduct of investigator/monitors meetings.
• Manage/coordinate the supply and reconciliation of Study Materials and Investigational product.
• Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.
• Quality contact person of the department and in charge on the development and implementation of all SOP
• Assist the staff recruitment
• Assist in business development in proposal generation and undertake feasibility work.
• Perform other related duties as assigned.

任职要求

• Experience conducting clinical trials with strong knowledge of GCP/ICH-GCP guidelines
• Experience making decision on the detailed execution of clinical trials
• Proven clinical trial experience with more than 3 years project management
• Medical life science background
• Fluent English is preferred
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