Job title Manager Clinical Operations Function R&D Operations Sub function Clinical Trial Project Management Category Manager, Clinical Trial Project Management (PL7) Location North Ryde / Eight Mile Plains / Osbourne Park / Australia Date posted Apr 28 2025 Requisition number R-011130 Work pattern Hybrid Work Description 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 Function: R&D OperationsJob Sub Function: Clinical Trial Project ManagementJob Category:People LeaderAll Job Posting Locations:Eight Mile Plains, Queensland, Australia, North Ryde, New South Wales, Australia, Osbourne Park, Western Australia, AustraliaJob Description:ABOUT THE COMPANY 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 THE OPPORTUNITYAs 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.RESPONSIBILITIESProvide 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 YOUBachelor'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 environment at a country level.
Visionary leader who can shape the organizational culture to improve adoption of future state.Experience in mentoring/coaching (line management experience desirable).
Proficient in decision-making and financial management.Flexible mindset and ability to work in a fast-changing environment.
Operates under limited supervision.Proficient in English language.
Computer literacy.
Strong interpersonal and negotiating skills.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
Perform activities in a timely and accurate manner.A preferred candidate has been identified for this particular role.
The purpose of advertising this role is aligned with our Global posting policy and in the spirit of transparency to identify other potential employees/candidates who may be interested in being considered for this position.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 CULTURECompetitive 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.