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Local Trial Operations Specialist

2 mesi fa

Roma, Lazio, Italia Johnson & Johnson A tempo pieno

Job Summary:

We are seeking a highly skilled Clinical Trial Operations Manager to join our team at Johnson & Johnson. As a key member of our clinical operations team, you will be responsible for managing local trial activities and project planning to meet site open and recruitment targets, while ensuring high-quality data is delivered on time and within study budget.

Key Responsibilities:

  • Collaborate with the Clinical Research Manager to assess protocol and site feasibility, implement consistent pre-trial assessment visit approaches, and set realistic start-up timelines.
  • Lead and coordinate local trial activities, project planning, and site management to meet site open and recruitment targets, and deliver high-quality data on time and within study budget.
  • Develop and implement contingency plans, drive issue resolution, and act as a subject matter expert for assigned protocols.
  • Establish and maintain excellent working relationships with external organizations and internal partners, including Medical Affairs, and review and approve monitoring reports.
  • Prepare country-specific informed consent forms, obtain country Ethics Committee and Health Authority approvals, and maintain oversight or initiate corrective and preventive actions.
  • Encourage and empower trial teams to deliver on trial commitments, prioritize patient engagement and safety, and contribute to process improvement initiatives.

Requirements:

  • A minimum of a BA or BSc degree in Life Sciences, Nursing, or a related scientific field (or equivalent experience).
  • Experience in clinical trials, preferably in site monitoring, and project management tasks.
  • Proven leadership skills, effective communication skills, and digital literacy.
  • Ability to lead initiatives and small teams, and proficiency in local language(s) and English.

What We Offer:

  • A competitive salary and extensive benefits package.
  • A flexible working environment that values work-life balance.
  • Career development opportunities for those who want to grow and be part of our organization.