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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
North Ryde, New South Wales, Australia
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THE OPPORTUNITY
The Manager, Clinical Research which plays a critical leadership role in the planning, execution, and oversight of clinical research activities supporting DePuy Synthes’ orthopedic portfolio. This role partners closely withcross‑functionalstakeholders to ensure clinical studies are scientifically sound, operationally efficient, and compliant with global and local regulatory requirements. The position offers the opportunity to directly influenceevidencegeneration that supports patient outcomes, product innovation, and regulatory and commercial success.
RESPONSIBILITIES
Lead end-to-end clinical study operations across assigned programs, including feasibility planning, vendor/CRO engagement, start-up, execution, and close-out activities.
Drive clinical site identification and selection by leading feasibility assessments (site experience, enrollment potential, quality history, contracting/start-up timelines), documenting rationale, and aligning final site lists with study strategy.
Ensure studies are executed in compliance with GCP, applicable country regulations, and internal procedures, including oversight of informed consent, safety reporting, essential documents, and data integrity expectations.
Serve as a primary clinical operations point of contact to cross-functional stakeholders (R&D, Medical Affairs, Regulatory, Quality, Biostatistics/Data Management) and external partners (CROs, investigators), ensuringtimelydecisions and clear documentation of actions and outcomes.
Develop andmaintainoperational study plans (milestones, enrollment projections, monitoring strategy, issue escalation pathways), track progress against timelines and budget, and proactively identify/mitigate risks to deliverables.
Own monitoring resourcing planning (FTE/visit forecasts, CRA allocation, coverage models) and coordinate with monitoring leadership/CROs to ensure adequate capacity, continuity, and quality oversight across sites.
Support inspection readiness andparticipatein audits/inspections by preparing study documentation, coordinating responses,facilitatinginterviews, and drivingtimelycompletion of corrective and preventive actions (CAPAs) for study-related findings.
Drive consistent project management and communication practices, including meeting cadences, status reporting, and lessons learned; collaborate effectively with a US-based global clinical team by planning across time zones and ensuringtimelyhandoffs and stakeholder updates.
ABOUT YOU
Required:
Bachelor’s degree in Life Sciences, Health Sciences, Engineering, ora relateddiscipline (required).
6–8 years of progressive experience in clinical research, clinical operations, or related medical device or healthcare research roles.
Demonstrated experience managing or leading clinical studies andcross‑functionalteams.
Strong knowledge of GCP, clinical research regulations, and quality systems.
Proven ability to manage multiple priorities, timelines, and stakeholders in a matrix environment.
Excellent written and verbal communication skills, including scientific and clinical documentation.
Desirable:
Advanced degree (Master’sor PhD) in a scientific or clinical discipline (preferred).
Experience within medical devices, orthopedics, or surgical products.
Priorpeople‑managementor matrix leadership experience.
Experience supporting regulatory submissions orpost‑marketclinical studies.
Familiarity with global clinical trial execution andinvestigator‑initiatedresearch.
Other:
Language: Englishproficiencyrequired
Travel: Up to 20% domestic and international travel may berequired
Certifications: Clinical research or project management certifications (e.g., ACRP, SOCRA, PMP) preferred.
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 accessible working arrangements for all.
Johnson & Johnson has announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company. The planned separation is anticipated to be completed within 18 to 24 months, subject to satisfaction of legal and regulatory requirements, and other customary conditions and approvals. Should you accept this position, it is anticipated that following conclusion of the transaction, you would be an employee of the standalone orthopaedics company and your employment would be governed by the standalone orthopaedics company’s employment processes, programs, policies and benefit plans. In that case, details of any planned changes would be provided to you by the standalone orthopaedics company at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making, Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements, Program Management, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management
At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.
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