Bachelors Degree or equivalent
5 years experience minimum
• Clinical trial experience in early drug development
• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
• Understanding of the tools of the trade, such as data standards (CDISC SDTM), data visualisations and clinical data capture.
- 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).
• 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.
• 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.
At GSK opportunities have arisen within Clinical Pharmacology Science & Study Operations. We are looking for experienced and innovative individual to join our early phase team to lead the delivery of studies to support the progression of the pipeline. This role is required to direct overall clinical data quality and data management activities at the asset, project or study level in support of GSK's medicine development strategy.
• 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, Operations and Science Leader or in close collaboration with these roles and 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.
You may apply for this position online by selecting the Apply now button.
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