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Job Function:
Data Analytics & Computational SciencesJob Sub Function:
BiostatisticsJob Category:
Scientific/TechnologyAll Job Posting Locations:
High Wycombe, Buckinghamshire, United KingdomJob Description:
As a Principal Portfolio Lead, Clinical Programming, this position is responsible for formulating the clinical programming strategy across a set of clinical trial and/or report activities, compound, disease, therapeutic or reporting group area, indication assigned of medium to high complexity. They are accountable for the effective planning and execution of programming activities across multiple clinical trials for their assigned portfolio ensuring effective partnership with, and management of stakeholders.
This position drives operational excellence, consistent implementation of data standards, program and report library templates and macros as programming lead. Accountable for effective resource allocation and utilization of resources as well as optimal assignment of work in accordance with sourcing decisions, people/ partnership development goals and business needs.
Additionally, they provide leadership and/or expertise in relevant technical areas and on process improvement, maintenance and innovation initiatives working proactively to connect with teams, peers and leadership within and cross functions, sharing and implementing lessons-learned and shaping processes and practices.
• Accountable for clinical programming strategy across assigned portfolio of medium to high complexity, scope and/or criticality within compound, disease area, indication or Therapeutic Area.
• Responsible for the planning, execution and completion clinical programming activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned area.
• Proactively evaluates and manages resource demand and allocation of internal and external team members to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems.
• Collaborates effectively with team and cross-functional counterparts and vendors to achieve project goals.
• Participates in hands on project or trial initiation activities, as needed.
• Contributes to and/or leads departmental innovation and process improvement projects and development of disease or therapeutic area standards, training as required, may contribute programming expertise to cross functional projects/initiatives.
• Ensures compliance of assigned teams and personnel with company and department SOP’s, policies and regulatory guidance documents.
• The position mentors and coaches and delegates work.
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Clinical Data Management, Collaborating, Compliance Management, Critical Thinking, Data Privacy Standards, Good Clinical Practice (GCP), Organizing, Presentation Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Research Documents, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Survey Design
