Principal Portfolio Lead Clin Prog

Principal Portfolio Lead, Clinical Programming

Job Function: Data Analytics & Computational SciencesJob Sub Function: BiostatisticsJob Category: Scientific/Technology

Responsibilities

• 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 of 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

• 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

Location: High Wycombe, Buckinghamshire, United Kingdom

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