Principal Clinical Data Manager
Location:
Posted:
November 03, 2016
Reference:
WD96609
Basic qualifications:
• Bachelors Degree or equivalent.
• 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.

Preferred qualifications:
Preferred Qualifications: • End-to-end global medicine development experience.
• Business acumen by understanding the implications of decisions from a business perspective and uses this knowledge to plan, implement and manage R&D, issues, projects and processes are aligned with business needs.
• Pharma, CRO and/or ARO experience. Demonstrates expertise in the identification, evaluation and selection of key global preferred provider partnerships. Ensures final contracts meet all technical and performance requirements for the appropriate business level, (asset, project or study.
• Understanding of local regulatory environment and commercial needs at a country level.
• Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area. Demonstrates scientific principles, practices and procedures to the clinical development process, knowing when and how to balance scientific and commercial interests to ensure optimum conditions for success.
• Demonstrates the project management
disciplines of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics.

Details:
•Accountability:

• Single point of accountability for data management deliverables at an assigned level (asset, project or study) within a given clinical development program.
• Global clinical project level contribution, as a Data Quality Leader in close collaboration with the study team. Includes working with representatives from Data Stewardship Operations and Standards.
• Global internal and external expert for more complex data management and data quality considerations. May be recognized as a global technical/business leader. Regularly provides expertise to others within and outside GSK.

• Expert input to protocol and other plans at the development phase of a study.
• Expert input to the strategic delivery plan for data capture tools across the studies of a clinical development program.
• Expert input to the Study Data Quality Plan throughout the lifecycle of the study.
• Expert input to the development of data capture tools for a clinical study, including the eCRF and ePRO.
• Development and management of study validation and integration plans, including the validation plan, dataset definition and external data sources.
• Ensures data is of the quality and integrity from source through to submission, publication and archiving.
• Expert input to Asset Strategy and Clinical Data Stewardship.
• Lead role in developing strategic partnerships.
• Participates in due diligence activities and risk assessments with specific emphasis on the data management and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships.
• Lead role in the management of the data vendor deliverables and performance.
• Subject Matter Expert for the Data Quality Community in a specified area(s) of functional expertise, which can include expert input to the development, implementation and communication of control documents.
• Coach and mentor within the Practices Community.
• Maintains Data Management Study File.
• Expert application of data management and data quality tools to efficiently deliver clinical development plan objectives.
• Data compliant with GSK's principles of data integrity in support of building public trust and maintaining GSK's corporate reputation.
• Purposeful challenges to the amount of data collected and validation efforts, driving a focus on fit for purpose and decision-making avoiding re-work.
• Clinical data stewardship with the effective development and use of standards and maximizing data re-use.
• Ensure clear delivery from data vendors and partners are compliant with GSK's principles of data integrity.
• Provides data quality feedback to site staff and monitors on a regular basis and identifies when re-training needed.

• Direct or matrix management and oversight of the deliverables from Clinical Data Scientist Professionals. May include staff located in multiple countries across multiple R&D sites.

• IPE and EPE budget forecasting and on-going budget management of data management operational contract staff and third party vendors for the assigned level (project or study).

Complexity:

• Leads deliverables for at least two global studies and/or one project at any point in time.
• Leadership role or Data Scientist Expert in global strategic level change and innovation projects, systems and/or processes spanning Data Quality Practice and/or having significant impact across Medicine Development (or across other R&D directorates).
• Champions the development and use of therapy area standards.
• Lead role with third party suppliers, assessing capability, managing delivery and performance.

• Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to manage Data Sciences operational 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.
• Process and tool change champion, driving innovative approaches to end-to-end asset / project / study delivery.
• Develops strategic solutions with new vendors irrespective of traditional organizational boundary 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 Quality topics.
• Develops recommendations for study or project issue resolution.
• Global internal and external expert for more complex data management and data quality considerations. May be recognised as a global technical/business leader. Regularly provides expertise to others within and outside GSK.
• 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.
• Influences key project [indication] or Empowered Study Team members or roles to meet the overall goal of the project or study.
• Active participant of the Data Quality Practice, influencing it's vision and objectives
• Data Quality contact for other Practices.
• 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 CIL, OSL, Statistician, Study Steward and other study team colleagues for data management and data quality agreements.
• Works within an extensive global network within the GSK Data Quality Community to ensure knowledge sharing and learning from the collective past experience.
• Leads 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.

• End-to-end global medicine development experience.
• Business acumen by understanding the implications of decisions from a business perspective and uses this knowledge to plan, implement and manage R&D, issues, projects and processes are aligned with business needs.
• Pharma, CRO and/or ARO experience. Demonstrates expertise in the identification, evaluation and selection of key global preferred provider partnerships. Ensures final contracts meet all technical and performance requirements for the appropriate business level, (asset, project or study.
• Understanding of local regulatory environment and commercial needs at a country level.
• Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area. Demonstrates scientific principles, practices and procedures to the clinical development process, knowing when and how to balance scientific and commercial interests to ensure optimum conditions for success.
• Demonstrates the project management disciplines of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics.

Contact information:

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