Lead Local Trial Manager

2 weeks ago


North Ryde, Australia Johnson & Johnson Full time

**Function**
- R&D Operations

**Sub function**
- Clinical Trial Project Management

**Category**
- Senior Analyst, Clinical Trial Project Management (P6)

**Location**
- North Ryde / Eight Mile Plains / Adelaide / Notting Hill, / Osbourne Park / Australia

**Date posted**
- Jun 25 2025

**Requisition number**
- R-017155

**Work pattern**
- Hybrid Work

Description

**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.

**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.
- Mentor and guide junior team members, contributing to their training and development.

**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 accessibl



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