Manager, Clinical Research

Antler

Sydney

On-site

AUD 150,000 - 190,000

Full time

13 days ago

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Competitive remuneration

Continuous training

Flexible working arrangements

Job summary

Johnson & Johnson in North Ryde, Australia is recruiting a Manager, Clinical Research to lead planning, execution, and oversight of clinical studies in orthopedics. The role partners with R&D, Medical Affairs, Regulatory and Quality to ensure scientifically sound and compliant programs that drive patient outcomes and product development.

You will manage site identification, feasibility, vendor relationships, start-up, monitoring, and CAPA processes, while aligning timelines and budgets across

Qualifications

Bachelor’s degree required in life sciences or related.
6–8 years in clinical research or clinical operations.
Experience leading cross-functional clinical studies.
Strong knowledge of GCP and regulatory requirements.
Excellent written and verbal communication.

Responsibilities

Lead end-to-end clinical study operations across assigned programs.
Drive site identification and feasibility assessments.
Ensure studies comply with GCP and regulations.
Serve as primary operations contact with cross-functional stakeholders.
Develop and maintain operational study plans and budgets.
Oversee monitoring resourcing and CRO coordination.
Support inspections and CAPA processes.
Coordinate global team communications across time zones.

Skills

Clinical operations lead

GCP knowledge

Cross-functional teamwork

Documentation skills

Stakeholder management

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Tools

CTMS

Contract management

Budgeting

Project management

Job 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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 & 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.

#DePuySynthesCareers

Preferred Skills