At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job Category:** Professional **All Job Posting Locations:** Adelaide, South Australia, Australia, Eight Mile Plains, Queensland, Australia, North Ryde, New South Wales, Australia, Notting Hill,, Victoria, Australia, Osbourne Park, Western Australia, Australia **Job Description:** + **Great Place to Work® Certified - 2024** + **Competitive salary package, flexible work practices** **, award winning benefits** + **Continuous training and development** **ABOUT INNOVATIVE MEDICINE** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine **THE OPPORTUNITY** An opportunity is now available for a Senior Clinical Project Manager/Lead Local Trial Manager to join our high performing Global Clinical Operations (GCO) team. The Lead, Local Trial Manager plays a crucial role in overseeing the local management of clinical trials within Australia. You will be your global project team’s local point of contact and will provide local project team oversight to achieve flawless execution of your assigned clinical trials. You will work closely with your Manager, Clinical Operations, however you will remain responsible for the conduct of your projects. You will cover all aspects of study execution from feasibility and pre-trial assessment through to database lock and close-out activities. The role extends more broadly to include, in some cases, leading a cross functional team or working on early development pipeline products. As an exceptional leader, you will build strong working relationships with internal and external customers and ensure the smooth running of our trials; delivering them on time, on budget and in accordance with Good Clinical Practice (GCP), relevant SOPs and regulatory requirements. In addition, you will be required to contribute to process improvement as well as training and mentoring other team members. The is a permanent, full-time role. **RESPONSIBILITIES** + 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. Johnson & Johnson, as a world leader across multiple therapy areas, offers a dynamic environment with opportunities to learn and grow across a broad range of those therapeutic areas. We encourage candidates with a strong desire to learn and a willingness to adapt to new challenges to apply. **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. And much more... **Great Place to Work® Certified– 2024** Great Place to Work® Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces. Johnson & Johnson - Australia and New Zealand was certified as a Great Place to Work® in ANZ in its first year of participation.