Job Summary
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 serve as the global project team's local point of contact and provide local team oversight to achieve flawless execution of your assigned clinical trials. You will work closely with your Manager, Clinical Operations, while remaining 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.
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.
* Develop strong therapeutic knowledge as a subject matter expert for assigned protocols.
* 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.
* 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 people leadership (coaching and mentoring) and customer focus. Demonstrated ability to lead initiatives or small teams.
* Willingness to travel.
Company Culture & Benefits
* Competitive remuneration package.
* Continuous training and support.
* Award‐winning leadership development programmes.
* Inclusive, flexible, and accessible working arrangements.
* Equal opportunity employer supporting diversity and inclusion.
* Up to 18 weeks of parental leave.
* 4 days of volunteer leave.
* Option to purchase up to 2 weeks of additional annual leave.
* Dedicated Wellbeing Day to prioritise self‐care.
* Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities.
* Access to an Employee Assistance Programme for personal and professional support.
* Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support.
* Life insurance coverage.
Additional Information
Great Place to Work Certified – 2025.
Candidates must be authorised to work in New Zealand and not require visa sponsorship at the time of application.
Job Details
* Job Function: R&D Operations
* Job Sub‐Function: Clinical Trial Project Management
* Job Category: Professional
* Location: North Ryde, New South Wales, Australia
* Employment Type: Permanent, Full‐time
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