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数据分析 Senior Study Data Manager

2024-03-29

数据分析 Senior Study Data Manager 面议
Department: 统计部
  • 江苏省||南京市||浦口区
  • 5-10年
  • 本科及以上
  • 全职
  • 1
职位描述:

Senior Study Data Manager

Location: Nanjing/Shanghai/Beijing

 

Scope of Responsibilities:

The Senior Study Data Manager is responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines; serve as representative in the study team; provide comprehensive data management expertise and support to team members; coordinate cross functional teams to ensure the flawless conduct of a clinical trial. 

  • Acting as one of study team core member; liaises directly with internal customers (Study Medical Manager, Statistician, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management activities for assigned study, discuss timelines and provide study Data management reporting. Proposes solutions for data management issues that arise during the conduct of a study, and monitor until resolution.
  • Planification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as planned.
  • Accountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements. Assures that data management standards are followed. Manages study document archiving in eTMF according to eTMF guidance. Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management function.
  • Defining and implementing the study data cleaning and validation strategy integrating risk based approach.
  • Involved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of study.
  • Coordinating, in collaboration with vendor external data activities : load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.
  • Participating in the implementation of department initiatives. Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures.
  • Managing service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.

Requirements:

  1. Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences) and 5+ years of experience in clinical data management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in data management is required.
  2. Knowledge of database structures and available tools to manage, extract, and report data is preferred.
  3. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas and external vendors.
  4. Exceptional organizational and problem-solving skills.
  5. Ability to establish and maintain good working relationships with different functional areas.
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