GSK
Healthcare
ProgrammingManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Programming Manager at GSK. Skills: Statistical programming, Data strategy, Agile methodology, Clinical trial analysis. Develop study roadmap. Manage study roadmap”
What You'll Achieve.
Ensure KPIs are met; Enhance programming efficiency; Reduce reporting duration; Increase quality; Maintain regulatory standards; Optimize project outcomes
Industry & Context.
Risk identification; Solution proposal; Technical issue guidance; Complex task solutions; Data-driven decision making; Mitigation plan devising
What They're Looking For.
Must Have
5+ years programming experience, Expertise in programming tools, Expertise in programming processes, Expertise in programming standards, Solid understanding of Jira, Solid understanding of AGILE principles
Nice to Have
Advanced expertise in tools, Advanced expertise in processes, Advanced expertise in standards, AI technology leverage experience, R-based tool development experience
What You'll Do.
Develop study roadmap
Generate study priorities
Generate study timelines
Generate study backlogs
Generate study sprints
Identify programming risks
Monitor programming risks
Escalate programming risks
Develop programming expertise
Implement programming standards
Lead programming deliverables execution
Execute programming deliverables
Create SDTM deliverables
Create ADaM deliverables
Create output specifications
Create regulatory documentation
Respond to Health Authority
Maintain data in forecasting tools
Maintain data in planning tools
Maintain data in workflow tools
Create oversight plan
Implement sponsor oversight
Advise on programming specifications
Advise on analysis plan
Advise on case report form
Advise on end-to-end data strategy
Advise on data management documents
Demonstrate knowledge of study design
Demonstrate knowledge of protocol
Demonstrate knowledge of submission standards
Demonstrate knowledge of indication domain data
Demonstrate knowledge of endpoints
Utilize expertise in programming languages
Develop clinical trial data analysis
Support clinical trial data analysis
Provide expert advice on technical issues
Provide guidance on technical issues
Ensure best practices are used
Lead discussions on programming strategies
Lead discussions on data strategies
Lead discussions on displays
Lead discussions on custom programs
Adapt to new processes
Adapt to multilingual programming
Keep abreast of GSK standards
Keep abreast of GSK processes
Mentor programming team
Inform programming team
Guide stakeholders on deliverables
Guide stakeholders on timeline planning
Identify risks proactively
Propose solutions for risks
Involve in after action reviews
Make data-driven decisions
Optimize programming processes
Enhance study operations
Leverage AI technology
Develop R-based tools
Enhance programming efficiency
Reduce reporting duration
Consult on programming requirements
Propose innovative solutions
Apply AGILE principles
Advocate for quality control
Adhere to quality control
Ensure accuracy of data
Ensure reliability of data
Ensure accuracy of analysis outputs
Ensure reliability of analysis outputs
Ensure submission readiness
Ensure audit readiness
Ensure programming adherence to process
Take corrective action for deviations
Ensure programming activities comply with SOPs
Ensure programming activities comply with industry standards
Ensure programming activities comply with regulatory requirements
Oversee compliance with TMF requirements
Maintain regulatory standards
Ensure timely archival of deliverables
Ensure timely archival of documentation
Establish governance frameworks
Uphold governance frameworks
Devise mitigation plans
Escalate for quicker action
Follow-up on escalations
Implement DIA principles
Implement SPADM principles
Articulate complex technical information
Collaborate with statisticians
Plan datasets for re-QC
Plan outputs for re-QC
Identify datasets for re-QC
Identify outputs for re-QC
Define study processes
Document study processes
Ensure understanding among programming team
Ensure alignment among programming team
Ensure understanding among matrix team
Ensure alignment among matrix team
Maintain proactive communication with stakeholders
Manage stakeholder expectations
Address stakeholder risks effectively
Influence project direction
Influence decision-making
Present compelling data
Present compelling insights
Develop working relationships with stakeholders
Sustain working relationships with stakeholders
Foster a collaborative environment
Initiate project management tools
Maintain project management tools
Review progress regularly
Provide inputs in working group meetings
Lead programming meetings
Lead kick-off meetings
Collaborate with Agile leaders
Ensure sufficient resources
Monitor study plan changes
Monitor resource planning impacts
Take accountability in developing timelines
Ensure timelines are updated
Discuss study requirements with PP
Discuss study requirements with cross-functional teams
Discuss timelines with PP
Discuss timelines with cross-functional teams
Ensure clarity on tasks
Ensure clarity on timelines
Facilitate integration across matrix teams
Leverage collective expertise
Present on technical topics
Present on leadership topics
How You'll Work.
Team & Collaboration
Cross-functional teams; Matrix teams; Agile leaders; Statisticians; PP; Stakeholders
Communication Scope
Technical information articulation; Stakeholder communication; Data presentation; Insight presentation
Process & Methodology
Agile framework, Roadmap planning, Timeline planning, Resource forecasting, Oversight plan, RACI matrix, Project milestone planning, Workflow tools
Full Job Description
**_Key Responsibilities:_** **1) Accountability** * Develop and manage the study roadmap in alignment with the Clinical Study Action Plan (CSAP) and Project Roadmap. * In collaboration with PP, generate study priorities, timelines, backlogs, and sprints within the Agile framework. * Proactively identify, monitor, and escalate risks associated with programming activities for their studies and develop understanding of the impact at the project level. * Develop advanced expertise in using the tools, processes, and standards and ensure these are implemented within the study. * Ensure Key Performance Indicators (KPIs) related to statistical programming and data strategy are met, including contribution to the Trial Master File (TMF). * Lead and contribute to the execution of programming deliverables such as: SDTM and ADaM datasets; tables, listings, and figures (TFLs) related to the Clinical Study Report; annotated case report form (aCRF); output specifications (i.e. mock shells); regulatory documentation such as reviewers’ guides, define.xml, and Health Authority responses. * Maintain accurate and timely data in resource forecasting tools, project milestone planning tools and collaboration workflow tools. * Create oversight plan and implement Sponsor oversight for outsourced studies. **2) Technical & Scientific Expertise** * Author or advise on programming specifications, analysis plan (SAP), protocol, case report form (eCRF), end-to-end data strategy, and data management documents. * Maintain and demonstrate in-depth knowledge of study design, protocol, submission standards and indication domain data and endpoints. * Utilize high-level expertise in programming languages (e.g., R, SAS) to develop and support clinical trial data analysis. * Provide expert advice and guidance on complex technical issues, ensuring best practices are used across the programming team. * Lead discussions on programming and data strategies, displays, and custom programs, adapt to new tools/pro
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