Senior Manager Clinical Operations - Early Development

Johnson & Johnson Johnson & Johnson · Pharma · High Wycombe, Buckinghamshire, United Kingdom

Senior Manager Clinical Operations for Early Development & Clinical Pharmacology (phase 0-IIa) trials, responsible for strategic and operational management, country execution, resource allocation, timeline and budget adherence, compliance with SOPs, policies, HCC, and local regulatory requirements. This role involves line management of Trial Managers, Site Managers, CTAs, and other GCO staff, overseeing performance, development, training, and issue resolution. The position also focuses on driving innovative solutions, process improvements, and ensuring inspection readiness for the portfolio.

What you'd actually do

  1. Providing line management to direct reports, including setting goals and objectives, conducting performance evaluations, and supporting talent development.
  2. Evaluating and forecasting resource needs for the assigned portfolio and coordinating plans with the Director, Early Development (EMEA/Americas).
  3. Supporting the flexible resourcing model by collaborating with Flex Resource managers to recruit, onboard, offboard, and assess flex staff performance.
  4. Interviewing, hiring, training, and developing team members.
  5. Ensuring understanding of relevant processes and procedural documents, and maintaining documented training compliance for direct reports.

Skills

Required

  • Clinical trial management
  • Early development and clinical pharmacology
  • Line management
  • Resource forecasting and allocation
  • Budget management
  • Regulatory compliance (ICH-GCP, local regulations)
  • Stakeholder communication
  • Talent development

Nice to have

  • Process improvement
  • Innovative solutions

What the JD emphasized

  • local regulatory requirements
  • compliance with relevant SOPs, policies, Health Care Compliance, and local regulatory requirements
  • ICH-GCP, relevant SOPs, and other procedural documents