**Job Function**:
R&D Operations
**Job Sub Function**:
Clinical Trial Project Management
**Job Category**:
People Leader
**All Job Posting Locations**:
Eight Mile Plains, Queensland, Australia, North Ryde, New South Wales, Australia, Osbourne Park, Western Australia, Australia
**ABOUT THE COMPANY**
**THE OPPORTUNITY**
As the Manager Clinical Operations, you will oversee the operational management of clinical trials within designated therapeutic areas. You will be accountable for executing all phases of clinical trials, ensuring effective resource allocation, adherence to timelines and budgets, and compliance with Standard Operating Procedures (SOPs), Health Care Compliance (HCC), and local regulatory requirements.
Supporting the Country Head, you will help shape and manage the local organisational structure for optimal efficiency. Your role will include line management of Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA), and other Global Clinical Operations (GCO) staff. This entails overseeing staff performance, providing training, managing project assignments, and facilitating workload distribution.
In this role, you will drive alignment of local goals with organisational objectives and promote innovative solutions and process improvements within your assigned therapeutic areas.
**RESPONSIBILITIES**
- Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
- Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
- Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.
- Accountable for the acquisition of new talents and development of human resources.
- Guide direct reports in issue resolution and communication with involved stakeholders.
- Lead organizational changes and effectively communicate on priority shifts as required.
- Review and approve expenses in compliance with the company policies.
- Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives.
- Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
- Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
- Define, execute or support of long term strategy in alignment with GCO, GD and JJIM R&D strategies to position the local and global GCO organization for success.
- Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
- Accountable for appropriate and timely issue escalation and reporting (suspicion)
- of fraud, scientific/ethical misconduct and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.
- Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
- Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
- Review operational and quality metrics regularly and drive follow-up actions as appropriate.
- Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/GD overall. Foster a culture of continuous improvement and innovation within the local GCO team.
- Model Credo based culture within the local GCO team.
**ABOUT YOU**
- Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
- Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
- Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.). Influential in improving the clinical research e