Manager, Clinical Research

Johnson & Johnson Johnson & Johnson · Pharma · North Ryde, NSW, Australia

Manager, Clinical Research role at Johnson & Johnson, focusing on leading clinical study operations for the orthopedic portfolio. Responsibilities include study planning, execution, site selection, ensuring regulatory compliance (GCP), stakeholder management, and supporting audits. Requires a Bachelor's degree with 6-8 years of clinical research experience.

What you'd actually do

  1. Lead end-to-end clinical study operations across assigned programs, including feasibility planning, vendor/CRO engagement, start-up, execution, and close-out activities.
  2. Drive clinical site identification and selection by leading feasibility assessments (site experience, enrollment potential, quality history, contracting/start-up timelines), documenting rationale, and aligning final site lists with study strategy.
  3. Ensure studies are executed in compliance with GCP, applicable country regulations, and internal procedures, including oversight of informed consent, safety reporting, essential documents, and data integrity expectations.
  4. Serve as a primary clinical operations point of contact to cross-functional stakeholders (R&D, Medical Affairs, Regulatory, Quality, Biostatistics/Data Management) and external partners (CROs, investigators), ensuring timely decisions and clear documentation of actions and outcomes.
  5. Develop and maintain operational study plans (milestones, enrollment projections, monitoring strategy, issue escalation pathways), track progress against timelines and budget, and proactively identify/mitigate risks to deliverables.

Skills

Required

  • Bachelor's degree in Life Sciences, Health Sciences, Engineering, or a related discipline
  • 6–8 years of progressive experience in clinical research, clinical operations, or related medical device or healthcare research roles
  • Demonstrated experience managing or leading clinical studies and cross‑functional teams
  • Strong knowledge of GCP, clinical research regulations, and quality systems
  • Proven ability to manage multiple priorities, timelines, and stakeholders in a matrix environment
  • Excellent written and verbal communication skills, including scientific and clinical documentation

Nice to have

  • Advanced degree (Master’s or PhD) in a scientific or clinical discipline
  • Experience within medical devices, orthopedics, or surgical products
  • Prior people‑management or matrix leadership experience
  • Experience supporting regulatory submissions or post‑market clinical studies
  • Familiarity with global clinical trial execution and investigator‑initiated research
  • Clinical research or project management certifications (e.g., ACRP, SOCRA, PMP)

What the JD emphasized

  • GCP
  • global and local regulatory requirements
  • GCP
  • clinical research regulations