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Position: Principal Clinical Data Manager
Location: Worli, Mumbai, Maharashtra, india
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
- 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
- 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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