Key Responsibilities
Innovation and Technical Excellence:
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Stay up-to-date with industry trends, best practices, and regulatory guidelines related to CDISC standards and real-world data.
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Identify opportunities for process improvements and implement innovative solutions to enhance efficiency and quality, while driving the adoption of CDISC and data standards
Project Involvement:
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Accountable for implementation and maintenance of CDISC standards (SDTM, ADaM, etc.) for real-world data projects and studies up for submission.
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Collaborate with cross-functional teams, including clinical programming, biostatistics, epidemiology, and data standards, to ensure the integration of CDISC standards into RWD processes.
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Develop and implement data mapping, transformation, and validation procedures to ensure compliance with CDISC standards.
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Provide expert guidance and support to project teams/vendors on CDISC standards, including training and mentoring team members.
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Review and validate datasets and supporting documentation to ensure they meet CDISC standards and regulatory requirements.
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Oversee the development, validation, and maintenance of complex statistical programs.
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Develop and maintain programming/data standards and best practices within the disease area.
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Identify gaps in business processes and convert them into opportunities
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Support team navigate the technical issues within a project
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Encourages, drives and monitors best CDISC practices in all the project deliverables
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Makes prudent decisions to achieve desired outcomes and recommends solutions.
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Demonstrate agility and support priority projects - ensure to share knowledge across the team
Use of Real-World Data in Clinical Trial Submissions:
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Familiarity with the integration and utilization of real-world data (RWD) in clinical trial submissions.
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Collaborate with study teams to ensure the appropriate application of CDISC standards for RWD in submissions.
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Stay informed about the evolving regulatory landscape and guidelines concerning the use of RWD in clinical trials.
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Demonstrate expertise with different guidelines on using RWD in clinical trial submissions.
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Stay updated with regulatory requirements, guidance documents and industry standards for real-world evidence studies up for submission.
Resource Management:
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Maintain a first time right mindset to ensure high-quality deliverables.
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Accountable for the accuracy and reliability of application of CDISC Standards.
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Implement and uphold quality assurance processes to maintain high standards.
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Foster a culture of ownership and accountability within the team.
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Conduct resource forecasting to ensure optimal allocation of resources.
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Implement strategies to manage and optimize programming resources.
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Effective resourcing strategy aligned with business priorities.
Collaboration and External Engagement:
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Ability to work effectively in an external environment, engaging with external partners and stakeholders.
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Communicate effectively with internal and external partners to address project needs and challenges.
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Represent the CDISC Expert for RWD in meetings and discussions with senior management and external collaborators.
Quality and Accountability:
Innovation and Technical Excellence:
-
Stay up-to-date with industry trends, best practices, and regulatory guidelines related to CDISC standards and real-world data.
-
Identify opportunities for process improvements and implement innovative solutions to enhance efficiency and quality, while driving the adoption of CDISC and data standards
Project Involvement:
-
Accountable for implementation and maintenance of CDISC standards (SDTM, ADaM, etc.) for real-world data projects and studies up for submission.
-
Collaborate with cross-functional teams, including clinical programming, biostatistics, epidemiology, and data standards, to ensure the integration of CDISC standards into RWD processes.
-
Develop and implement data mapping, transformation, and validation procedures to ensure compliance with CDISC standards.
-
Provide expert guidance and support to project teams/vendors on CDISC standards, including training and mentoring team members.
-
Review and validate datasets and supporting documentation to ensure they meet CDISC standards and regulatory requirements.
-
Oversee the development, validation, and maintenance of complex statistical programs.
-
Develop and maintain programming/data standards and best practices within the disease area.
-
Identify gaps in business processes and convert them into opportunities
-
Support team navigate the technical issues within a project
-
Encourages, drives and monitors best CDISC practices in all the project deliverables
-
Makes prudent decisions to achieve desired outcomes and recommends solutions.
-
Demonstrate agility and support priority projects - ensure to share knowledge across the team
Use of Real-World Data in Clinical Trial Submissions:
-
Familiarity with the integration and utilization of real-world data (RWD) in clinical trial submissions.
-
Collaborate with study teams to ensure the appropriate application of CDISC standards for RWD in submissions.
-
Stay informed about the evolving regulatory landscape and guidelines concerning the use of RWD in clinical trials.
-
Demonstrate expertise with different guidelines on using RWD in clinical trial submissions.
-
Stay updated with regulatory requirements, guidance documents and industry standards for real-world evidence studies up for submission.
Resource Management:
-
Conduct resource forecasting to ensure optimal allocation of resources.
-
Implement strategies to manage and optimize programming resources.
-
Effective resourcing strategy aligned with business priorities.
Collaboration and External Engagement:
-
Ability to work effectively in an external environment, engaging with external partners and stakeholders.
-
Communicate effectively with internal and external partners to address project needs and challenges.
-
Represent the CDISC Expert for RWD in meetings and discussions with senior management and external collaborators.
Quality and Accountability:
-
Maintain a first time right mindset to ensure high-quality deliverables.
-
Accountable for the accuracy and reliability of application of CDISC Standards.
-
Implement and uphold quality assurance processes to maintain high standards.
-
Foster a culture of ownership and accountability within the team.
Stakeholder Management:
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Drive stakeholder engagement (internal & external) by identifying their needs, collaborating with them, communicating expectations, timelines and issues, suggesting and implementing solutions and ensuring alignment with business objectives.
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Identifies and creates a process for stakeholder engagement and propagates these processes to the team to be followed like communication, assistance beyond regular book of work
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Collaborate with internal RWDMA and cross-functional teams, including Clinical Programming, to deliver high-quality deliverables.
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Communicate complex technical concepts to non-technical stakeholders effectively.
Quality, Governance and Auditing:
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Develop responses to audit/inspection questions and assists in completing CAPAs within agreed timelines
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Has to act as an auditor for the team to make sure the team adheres to the defined quality standards
Change Management :
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Ensures that the team members have the resources available to adapt to changes quickly without effecting the deliverables
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Act as change agent and make team understand the rationale behind any changes be it timeline, technology or organizational structure
Recruitment and Retention strategy:
Accountability for impact:
Training and Development:
Inspires and Engages
Education Requirements
Advanced degree (Masters or Ph.D.) in Life Sciences, Epidemiology, Biostatistics, Public Health, Computer Sciences, Mathematics, Statistics or a related field with applicable experience
Job Related Experience
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Minimum 10 years of experience in the implementation of CDISC standards (SDTM, ADaM, etc.) and with the requirement of submission package (Define.xml, SDRG, ADRG etc) within the pharmaceutical or healthcare industry.
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Strong knowledge of real-world data sources, including electronic health records (EHR), claims data, and registries.
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Familiarity with regulatory requirements and guidelines related to CDISC standards and real-world data.
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Familiarity with FHIR/OMOP and other common data models is preferred
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Experience in clinical research and development.
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Expertise in R with proficiency in other programming languages such as SAS, or Python.
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Proven track record of leading projects and delivering high-quality results within tight timelines.
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Excellent problem-solving skills and ability to think strategically and innovatively.
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Experience of working in global matrix environment and managing stakeholders effectively
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Experience of using technologies to bring efficiency as well as in simplifying processes
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Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
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Demonstrated learning agility, with the ability to quickly adapt to new information and changing environments.
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Commitment to delivering high-quality work and ensuring data accuracy and integrity.
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Strong sense of accountability, taking ownership of tasks and delivering on commitments.
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A growth mindset, open to feedback and dedicated to continuous improvement and development.
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Experience with developing standards for big datasets; Familiarity with the common data models is preferred
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Ability to manage multiple projects and priorities in a fast-paced environment.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. .
