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Ensure that all project programming activities are aligned with strategic business goals and are conducted within the established timelines and budgets.
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Establish clear roles and responsibilities to drive efficiency, transparency, and accountability across all stakeholders.
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Ensure accurate and timely resourcing estimates for the portfolio by empowering teams to maintain data in tools for precise project planning and budget requirements.
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Oversee the development and management of the Project Roadmap in partnership with key stakeholders, aligning with the Clinical Development Plan (CDP).
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Regularly monitor Key Performance Indicators (KPIs) for programming, identifying risks, proposing solutions, and making timely decisions
Technical Expertise, Scientific Leadership & Strategy
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Champion the adoption of opensource mindset in the team and provides technical solutions to broader project technical and scientific requirements.
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Lead the identification of systemic gaps and opportunities across clinical programming processes and standards or in area of expertise, developing and executing strategic plans to embed best practices and optimize programming activities.
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Proactive engagement with emerging trends and advancements in clinical programming, applying these to the broadest impact.
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Represent programming in internal and external discussions to communicate concepts and decisions relating to programming to advance technical capability (e.g., tools, processes, standards, best practices and data-driven insights).
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Utilize comprehensive therapeutic knowledge to identify study-specific challenges and proactively create programming solutions tailored to address key research questions and support clinical trial objectives of a compound.
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Act as a programming function expert, influencing departmental and cross-departmental initiatives to support strategies that drive scientific and operational objectives.
Innovation, Problem Solving & Decision Making
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Drive the adoption of new technology within the team by acting as an advocate, ensuring tools and methodologies are effectively integrated into workflows. Provide guidance, share best practices, and identify opportunities to leverage technology for improved outcomes.
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Champion the adoption of industry standards, best practices, innovative tools and methodologies to enhance programming capabilities, streamline processes, and lead technical initiatives to drive efficiency within and across projects, within the team or department.
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Promote continuous improvement by experimenting and implementing enhancements to existing processes, leveraging tools and methodologies to address project challenges and support evolving business needs.
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Champion the adoption and innovative use of Artificial Intelligence/Machine Learning (AI/ML) tools across project team and within clinical programming.
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Lead teams providing new directions, novel strategies and innovative solutions to solve highly technical problems and drive efficiencies within and across projects.
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Serve as an escalation point for study and project-level issues impacting programming, managing the scope and delivery of outsourced activities with oversight and technical approval.
Compliance, Quality and Governance
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Advocate for rigorous quality control to maintain the accuracy and reliability of data outputs and compliance with standards.
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Ensure that all deliverables meet rigorous quality standards and regulatory compliance requirements, fostering a first time-right mindset.
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Implement governance frameworks along with continuous improvement practices to uphold quality standards and regulatory adherence.
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Identify risks early and devise mitigation plans; ensure timely escalation for quicker action and follow-up.
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Ensure timely archival of completed programming deliverables and documentation for studies and projects.
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Lead, coordinate or contribute to After Action Reviews (AARs), audit responses, implementation of agreed solutions and/or Corrective and Preventative Actions (CAPAs) relevant to the function, and facilitate sharing of learnings.
