Lead Local Trial Manager

4 days ago

North Ryde, New South Wales, Australia Johnson & Johnson Full time $90,000 - $120,000 per year
Job Function:

Professional
Job Description:
  • Great Place to Work Certified - 2024
  • Competitive salary package, flexible work practices, award winning benefits
  • Continuous training and development
THE OPPORTUNITYRESPONSIBILITIES
  • Lead country protocol and site feasibility assessments in collaboration with relevant stakeholders, ensuring adherence to local site selection criteria.
  • Contribute to country-level study management documents and support documentation for global studies as needed.
  • Coordinate local trial team activities, ensuring compliance with SOPs and regulations while meeting recruitment targets and delivering high-quality data within budget.
  • Monitor trial progress, implementing corrective and preventive actions when necessary, and communicate issues to the study management team.
  • Update trial management systems and analyse trial progress using available tools and reports.
  • Facilitate and lead Investigator Meetings and local trial team meetings, providing training and support as necessary.
  • Review and approve site and vendor invoices, manage local study supplies, and ensure compliance with informed consent and regulatory requirements.
  • Act as the primary local contact for the trial, fostering strong relationships with both internal and external stakeholders.
  • Act as a subject matter expert for assigned protocols and develop strong therapeutic knowledge.
  • Mentor and guide junior team members, contributing to their training and development.
  • Lead process improvement initiatives and take on additional responsibilities as a subject matter expert or champion for specific projects.
ABOUT YOU
  • Degree in Science, Nursing or Life Sciences.
  • Minimum of 6 years of clinical trial management experience or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience.
  • Strong project management experience for complex studies involving first in human and healthy volunteer cohorts.
  • Therapeutic knowledge in Hematology and Oncology is highly regarded.
  • Excellent communication and problem-solving skills.
  • In-depth understanding of the drug development process including GCP and local regulatory requirements.
  • Strong stakeholder management and customer focus. Demonstrated ability to lead initiative/small teams.
  • Willingness to travel.
COMPANY CULTURE
  • Competitive remuneration package.
  • Continuous training and support.
  • Award-winning leadership development programs.
  • Inclusive, flexible, and accessible working arrangements.
  • Equal opportunity employer supporting diversity and inclusion.
WHY CHOOSE US:
  • Competitive remuneration package and continuous training.
  • Supportive environment with award-winning leadership development programs.
  • Inclusive, flexible, and accessible working arrangements for all.
OUR BENEFITS:
  • Up to 18 weeks of parental leave to support new parents.
  • 4 days of volunteer leave to give back to the community.
  • Option to purchase up to 2 weeks of additional annual leave for extra time off.
  • Enjoy a dedicated Wellbeing Day to prioritize self-care.
  • Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities.
  • Access to an Employee Assistance Program for personal and professional support.
  • Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support.
  • Life insurance coverage for added peace of mind.

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