再鼎医药 · Biometrics 生物计量

Senior Specialist, Data Management

薪资面议  /  上海

今天 11:47 更新

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职位属性

  • 招聘类型:社招
  • 工作性质:全职
  • 同步至:海外网站&国内网站

职位描述

Primary Function:

To support Departmental business needs identifying by management team or other special assignments/tasks

Be accountable and/ or responsible for assigned project including but not limited to DM activities, vendor activities, and project deliverables.

Acting as POC (point of contact) for assigned project of all data management activities in difference phase and can provide DM expertise for different DM issues;

Major Responsibilities and Duties:

Project Management:

  • Serve as Data Manager with minimal supervision for one or more clinical trials assuming responsibility for DM activities including but not limited to data review and query management, Data Management metrics reporting, development and maintenance of the Data Management Plan, database testing, database release, and submission related activities.
  • In collaboration with the DM project lead and study team, ensure operational excellence across all DM deliverables.
  • Ensure work carried out in accordance with applicable SOPs and working guidelines as required.
  • Ensure the required study-specific DM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
  • Ensure operational excellence in collaboration with DM Project Lead for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.
  • Liaise with Non-CRF data vendors in a project-manager capacity in support of DTS setup, data transfer, timelines and data-related deliverables.
  • Create, review and revise data management documentation.
  • For assigned non-oncology studies: review protocols for proper data capture including electronic Case Report Form design. Able to perform a thoroughly detailed review of eCRF data requirements. Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans etc.
  • For assigned non-oncology studies: Lead studies as DMPL (Data Management Project Lead), identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

Process and Initiative:

·       Participates initiatives including but not limited to CRF data standard library set up and maintenance, Training, Mentorship, Standard Report and Smart Listings set-up.

任职条件

任职要求 Qualifications:

  • More than 3 years Data Management experience within Biopharma/CRO environment required. Oncology/Immuno-Oncology experience is preferred.
  • Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP, NMPA, HGR, FDA & ICH, GCDMP, CDISC and MedDRA/WHO-Drug.
  • Demonstrated knowledge of data management processes and principles in area of responsibility.
  • Working knowledge of full life cycle of clinical trials and ability to assess and determine study requirement from protocol review
  • Demonstrates strong verbal and written communication skills including ability to communicate remotely
  • Proficient experience using commercial clinical data management systems and/or EDC products (Rave preferred)
  • Experience using data visualization tools (e.g. Spotfire, J-Review, JMP) preferred
  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
  • Bachelor or Master’s degree in a health care or scientific related field preferred.