Manager, Clinical Research

Biopharma Careers; Sydney; On-site; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive remuneration package

Continuous training and support

Award-winning leadership development

Job summary

DePuy Synthes in North Ryde, Australia, is seeking a Manager, Clinical Research to lead end-to-end study operations across orthopedic programs. You will partner with R&D, Medical Affairs, Regulatory, and Quality to ensure scientifically sound and compliant trials with global and local requirements, delivering impactful evidence for patient outcomes and product success.

You will own study plans, budgets, timelines, and risk management, while guiding cross-functional teams and external CRO

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline is required.
• 6–8 years of progressive experience in clinical research or clinical operations.
• Experience leading cross-functional teams and managing clinical studies.
• Strong knowledge of GCP, regulations, and quality systems.
• Ability to manage multiple priorities and stakeholders in a matrix environment.
• Excellent written and verbal communication of scientific/clinical docs.

Responsibilities

• Lead end-to-end clinical study operations across assigned programs, including feasibility planning, vendor/CRO engagement, start-up, execution, and close-out.
• Drive site identification and selection by 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), ensuring timely decisions and clear documentation of actions and outcomes.
• Develop and maintain operational 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 and participate in audits/inspections by preparing study documentation, coordinating responses, facilitating interviews, and driving timely completion 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 ensuring timely handoffs and stakeholder updates.

Skills

Budgeting

CTMS

Clinical Trials

Contract Management

Developing Others

Execution Focus

Inclusive Leadership

Leadership

Process Improvements

Program Management

Project Integration Management

Research Ethics

Resource Planning

Team Management

Education

Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline

Master’s or PhD in a scientific or clinical discipline

Tools

CTMS

Job description

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

Job Description:

DePuy Synthes is recruiting for a Manager, Clinical Research in North Ryde, Australia

Join our change journey at J&J, help shape what’s next

Step into a high-impact career opportunity with real visibility

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 with cross ‑ functional stakeholders to ensure clinical studies are scientifically sound, operationally efficient, and compliant with global and local regulatory requirements. The position offers the opportunity to directly influence evidence generation 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), ensuring timely decisions and clear documentation of actions and outcomes.
• Develop and maintain operational 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 and participate in audits/inspections by preparing study documentation, coordinating responses, facilitating interviews, and driving timely completion 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 ensuring timely handoffs and stakeholder updates.

ABOUT YOU

Required:

• Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline (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 and cross ‑ functional teams.
• 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’s or PhD) in a scientific or clinical discipline (preferred).
• Experience within medical devices, orthopedics, or surgical products.
• Prior people ‑ management or matrix leadership experience.
• Experience supporting regulatory submissions or post ‑ market clinical studies.
• Familiarity with global clinical trial execution and investigator ‑ initiated research.

Other:

• Language: English proficiency required .
• Travel: Up to 20% domestic and international travel may be required .
• 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 & Johnsonisan 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,stateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section503 of the RehabilitationAct.

Johnson & Johnsoniscommitted to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contactAskGSto be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers

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