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Position: Principal Clinical Data Manager

Location: Worli, Mumbai, Maharashtra, india

Job Description:

Job Purpose

To deliver the data management components of a series of clinical studies or project from data capture from multiple sources, through improving in-stream data flow, data cleanliness and data integration.

Key Responsibilities :

  • Global study level contribution as Study Data Manager (SDM) or in close collaboration with SDM and other members of the study team.
  • Point of contact for more complex data management and data quality considerations including regular contact with monitors.
  • Provides input to protocol and other plans e.g. Monitoring Plan, Protocol Deviation Management Plan, and Reporting & Analysis Plan during the planning phase.
  • Manages in-stream data flow activities and delivers a quality database in accordance with the Data Management Plan.
  • Inputs into the data capture tools for a clinical study, including the eCRF and eCOA.
  • Develops and manages the Data Management Plan, execution of the validation and integration plans, including dataset definitions and external data sources. Manages vendor performance against study-specific Service Level Agreements.
  • Responsible for the set-up and maintenance of TMF section 10 and DM TMF artifacts throughout the study life cycle.

  • Trains monitors and site staff on the use of data collection tools and query management processes.
  • Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise.
  • Accountable for the development of the Study Data Quality Plan to ensure data is fit for purpose of the study
  • Lead database release and freeze activities, ensuring released data fulfilled quality level defined in Study Data Quality Plan
  • Ensure completion and lifecycle management of all data management related documents
  • Ensure data quality focusing activities and related records are ready for audit
  • Builds relationship with external organizations such as CROs, AROs, and other business partners to ensure the integrity of data captured by other organizations.
  • Engage EST, CRF/eCRF designer/programmer, Statisticians, Monitors, site staff and other stakeholders with the necessary expertise, in development of data capturing tool(s)
  • Accountable for data quality operational oversight with site monitoring staff

Job-Related Skills/Background

Project Scope

  • Leads deliverables for at least two global studies or multiple early phase studies and/or at least one project at any point in time.
  • Champions the development and use of therapy area standards.
  • Lead role with third party suppliers, assessing capability, managing delivery, and performance.

Creating Business solutions –

  • Operates across a global, complex organization.  Includes applying the processes, methods, tools, and approaches used to manage data management activities, staff, and the day-to-day running of a project or study-aligned team.
  • Maintains competitive advantage by creating sustainable strategies through gathering wide and varied information on all aspects of the business and its environment, exploring all future possibilities, and assessing strategic options.
  • Provides appropriate input regarding building core capabilities and across Practices.
  • Develops strategic solutions with new vendors irrespective of traditional organizational boundaries or country location.
  • Develops and implements new data types and therapy area standards.
  • Provides consultation as a Subject Matter Expert in one or more Data Management topic areas.

  • Develops recommendations for study or project issue resolution.Influence & Communication
  • Builds influential networks within and outside the organization.  Uses these relationships to generate buy-in and support for the project or Study Data Quality Plan to ensure mutually advantageous resources and goals.
  • Develops recommendations beyond own area of expertise.
  • Leads discussions with new partners and acquisitions in the conduct of due diligence and risk assessment.
  • Gains buy-in from the Medical Affairs (CSL), Study Delivery Lead (SDL), Statistician and other study team colleagues for data management and data quality agreements.
  • Leads to operational excellence and data quality focus negotiations with vendors and strategic partners.
  • Communicates technical topics to a non-technical audience.
  • Uses an extensive network within GSK and external to keep abreast of industry trends and be part of the development of those trends.

Qualification: Post Graduation in Scientific Discipline

Experience:

  • Clinical Trial Experience,
  • Knowledge of the principles of quality, safety, risk management, and compliance (ICH and GCP).
  • Understanding of the tools of the trade, such as standards.

Job-Related Experience :

  • Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs
  • Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard.
  • Deep and broad knowledge and skills in Clinical Data Management and data standards
  • Good knowledge and skills in computer programming and systems
  • Good communication skills
  • Demonstrates the discipline of risk-based planning
  • Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets

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