2) Technical & Scientific Expertise
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Review and advise on programming specifications, analysis plan (SAP), protocol, case report form (eCRF), end-to-end data strategy, and data management documents.
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Develop in-depth knowledge of study design, protocol, submission standards and indication domain data & endpoints.
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Utilize high-level expertise in programming languages (e.g., R, SAS) to develop and support clinical trial data analysis.
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Provide expert advice and guidance on complex technical issues, ensuring best practices are used across the programming team.
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Lead discussions on programming strategies, displays, and custom programs, adapt to new tools/process/multilingual programming.
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Keep abreast of GSK standards, processes, and updates; mentor and inform the programming team accordingly, guide stakeholders to better understand Programming deliverables and timeline planning, storytelling of milestones/deliverables.
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Be familiar with workflow tools like Jira.
3) Innovation, Problem Solving & Decision Making
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Proactively identify risks and propose solutions, active involvement to after action review discussions (AAR).
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Make data-driven decisions that optimize programming processes and enhance study operations.
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Gain expertise in leveraging AI technology and building R-based tools to promote automation, enhance programming efficiency, reduce reporting duration, and increase quality.
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Consult with PP and subject matter experts on programming requirements and propose effective, innovative solutions for complex tasks.
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Adopt new technologies and methodologies to improve programming efficiency and data analysis capabilities.
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Familiarity with AGILE principles (e.g., flexibility, collaboration, and continuous improvement) and how to effectively apply them within the context of STOM and study activities.
4) Compliance, Quality and Governance
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adhere to rigorous quality control to ensure and maintain the accuracy and reliability of data and analysis outputs and submission and audit readiness.
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Ensure programming s adherence to process, take corrective action for any programming related process deviations.
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Ensure all programming activities comply with industry standards and regulatory requirements, such as FDA and EMA guidelines.
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Oversee compliance with Trial Master File (TMF) requirements to maintain regulatory standards.
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Ensure timely archival of completed programming deliverables and documentation.
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Uphold and contribute to governance frameworks to ensure consistent application of programming standards and practices.
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Identify risks early and devise mitigation plans, timely escalation for quicker action and follow-up.
5) Communication and Influence
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Implement DIA and SPADM principles for effective meetings and faster decision making.
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Articulate complex technical information effectively to both technical and non-technical audiences, ensuring transparency and understanding of programming activities and timelines.
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Collaborate with statisticians and (PP) to plan and proactively identify datasets and outputs for re-QC (including Risk Based QC) for outsourced studies.
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Collaborate effectively to define and document study processes, ensuring comprehensive understanding and alignment among programming and matrix team members.
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Maintain proactive communication with stakeholders to manage expectations and address risks effectively.
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Play a pivotal role in influencing project direction and decision-making by presenting compelling data and insights.
6) Collaboration and Matrix-Working
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Develop and sustain strong working relationships with stakeholders to foster a collaborative environment.
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Initiate and maintain project management tools and Responsible Accountable Consulted Informed matrix (RACI).
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Engage stakeholders and review progress regularly (example: active participation in STOM providing necessary inputs in working group meetings).
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Lead or co-lead programming meetings and kick-off meetings (KOM).
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Closely collaborate with PP and Agile leaders to ensure sufficient resources and monitor any change in study plan which impacts the resource planning.
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Take accountability in developing the timelines, ensure these timelines are updated in tracking tools consistently.
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Effectively discuss the study requirements and timelines with PP and cross-functional teams for alignment and ensure clarity on tasks and timelines among team members.
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Facilitate seamless integration across matrix teams, leveraging collective expertise for optimal project outcomes.
