Manager, Gco Learning

**Job Function**:
R&D Operations
**Job Sub Function**:
Clinical Trial Project Management
**Job Category**:
Professional
**All Job Posting Locations**:
North Ryde, New South Wales, Australia
- ** Great Place to Work® Certified - 2024**:

- ** Johnson & Johnson named a 2025 Fortune World’s Most Admired Company**:

- ** 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**

The Clinical Trial Learning & Training (CTL&T) organization develops and implements training strategy and design for clinical trial training and GCO functional role-based global onboarding programs. This includes determining training needs, developing, and implementing strategic learning initiatives, and leveraging resources to deploy the training plan. CTLT delivers impactful learning and training programs that address gaps and build capabilities to meet future needs while ensuring compliance with relevant Regulations, Standards, and Good Clinical Practice. The organization aims to enhance the effectiveness of learning for those conducting clinical trial activities, improve site engagement/satisfaction and enhance preparedness of GCO roles that support portfolio services.

The Manager, GCO Learning & Training is responsible for the oversight, training strategy/delivery of Investigational Product (IP) across relevant GCO roles and sites. Activities include development of the strategy for engaging with investigational sites as it relates to IP and serving as the internal primary point of contact for GCO. Deliver strategic insights and constructive feedback to refine IP study-related documentation, drive the training initiatives, and oversee the resolution of IP-related issues at the site level.

The Manager, GCO Learning & Training will ensure that there is a strategic approach to connect with key stakeholders and will directly partner with the GCO Site Managers, Local Trial Managers, Independent Drug Monitors, and Delivery Unit Trial Delivery Leaders. In addition, there will be close partnering with the IP author as well as relevant stakeholders responsible for inputs to facilitate a successful design of the IP Preparation or Administration instructions, along with seamless execution of study protocols.

**RESPONSIBILITIES**
- Portfolio oversight within assigned therapeutic area to ensure alignment/consistency across the portfolio.
- Support development of high-quality training solutions leveraging a variety of techniques for transfer of knowledge.
- Provides consultation as Subject Matter Experts through the training strategy process to produce high-quality education materials.
- Facilitate training needs assessment as applicable with various teams to define plans with clear learning objectives.
- Lead internal, sponsor training providing intensive support depending on IP complexity. Act as the main point of contact for resolution of any questions associated with IP.
- Demonstrates strong presence and authority, leading discussions and ensuring training strategy meets all quality, regulatory, and operational expectations.
- Effective leadership skills, ability to develop and implement strategies, and to foster team productivity and cohesiveness is required.
- Support the pharmacy/Investigational Product (IP) related inspection readiness activities and provide inputs and follow up on audit CAPAs.
- Monitor key risk IP indicators, escalate, and mitigate as required.
- Excellent organization skills and the ability to collaborate and handle multiple priorities within a matrix environment is required.
- Persuasively communicates with relevant internal stakeholders. Confidently advocates for best practices, ensuring all stakeholders adhere to high-quality standards. Takes decisive action to resolve inconsistencies, challenge unclear guidance, and escalate concerns when necessary.

**ABOUT YOU**
- Bachelor’s degree in pharmacy/nursing, with an active license. Advanced degree in a scientific discipline and/or master’s degree are preferred. Within US, PharmD is required.
- Minimum of 5 years’ experience in compounding/nursing in clinical or hospital setting.
- Oncology experience required; Immunology experience preferred.
- Minimum of 5 years’ experience in clinical research experience acquired in pharmaceutical industry, CRO or investigational site is required.
- Early Development/First-in-human previous clinical trial experience is required.
- Strong knowledge of drug development, clinical research operations and regulatory requirements, including ICH-GCP, GMP and applicab