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Manager, Clinical Research

Johnson & Johnson
North Ryde, AUS
Full-time
Manager · 6–8 years experience
Hybrid
Discovered 1 weeks ago
gcp

Full Job Posting

RESPONSIBILITIES

  • Serve as the Australia-based clinical research lead and primary interface with the global clinical team, bringing forward regional clinical practice, customer, regulatory, reimbursement, and evidence needs to inform global evidence-generation plans.
  • Partner with Medical Affairs, Regulatory, Market Access, R&D, Marketing, and other local stakeholders to identify evidence gaps and priorities for Australia and the broader region, and translate them into clear recommendations for the global clinical strategy.
  • Lead or support local execution of medical device clinical studies, including feasibility, site identification and selection, start-up, enrollment, monitoring oversight, issue resolution, close-out, and study documentation.
  • Manage local CRO and vendor activities, including scope alignment, performance oversight, timeline and budget tracking, risk escalation, and quality of deliverables.
  • Build and maintain effective relationships with orthopedic investigators, clinical sites, research networks, and relevant national or regional clinical quality registries.
  • Support interactions and evidence activities involving the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and other national joint or medical device registries, including data requests, analyses, research collaborations, and interpretation of registry evidence.
  • Ensure studies are conducted in compliance with ISO 14155, ICH GCP as applicable, Australian regulatory and ethics requirements, other relevant country regulations, and internal quality procedures, with strong oversight of informed consent, safety reporting, essential documents, and data integrity.
  • Develop and maintain operational study plans, enrollment projections, milestones, monitoring approaches, and escalation pathways; proactively identify and mitigate risks to timelines, budget, quality, and evidence deliverables.
  • Support audit and inspection readiness by maintaining complete study documentation, coordinating responses, facilitating interviews, and driving timely completion of corrective and preventive actions for study-related findings.
  • Provide clear status reporting, decision support, and timely handoffs across time zones to maintain alignment between local stakeholders and the US-based global clinical team.
  • ABOUT YOU
  • Required:
  • 6–8 years of progressive clinical research or clinical operations experience, including substantive hands-on experience conducting or overseeing industry-sponsored clinical research, preferably for medical devices.
  • Demonstrated experience managing medical device clinical studies across multiple phases of execution, such as feasibility, study start-up, site management, monitoring oversight, vendor/CRO management, close-out, or post-market evidence generation.
  • Knowledge of medical device clinical research standards and regulations, including ISO 14155, applicable GCP principles, ethics requirements, safety reporting, and quality-system expectations.
  • Experience working with global and local cross-functional teams and communicating regional evidence needs, risks, and recommendations to global stakeholders.
  • Proven ability to manage CROs, vendors, clinical sites, multiple priorities, timelines, and stakeholders in a matrix environment.
  • Excellent written and verbal communication skills, including preparation and review of clinical, scientific, operational, and regulatory documentation.
  • Desirable:
  • Clinical research experience in orthopedics, joint replacement, trauma, spine, sports medicine, or other implantable or surgical medical devices.
  • Experience interacting or collaborating with the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), another national joint replacement registry, or a comparable medical device or clinical quality registry.
  • Experience using registry or real-world data to identify evidence gaps, support post-market surveillance, evaluate device performance, or inform clinical, regulatory, reimbursement, or market access strategies.
  • Knowledge of the Australian medical device research environment, including local ethics, governance, regulatory, site, and investigator requirements.
  • Experience supporting regulatory submissions, post-market clinical follow-up, investigator-initiated research, or externally sponsored research for medical devices.
  • Prior matrix leadership or people-management experience.
  • 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.
  • #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
  • Certifications: Clinical research or project management certifications (e.g., ACRP, SOCRA, PMP) preferred.

Qualifications

  • 6–8 years of progressive clinical research or clinical operations experience, including substantive hands-on experience conducting or overseeing industry-sponsored clinical research, preferably for medical devices.
  • Demonstrated experience managing medical device clinical studies across multiple phases of execution, such as feasibility, study start-up, site management, monitoring oversight, vendor/CRO management, close-out, or post-market evidence generation.
  • Knowledge of medical device clinical research standards and regulations, including ISO 14155, applicable GCP principles, ethics requirements, safety reporting, and quality-system expectations.
  • Experience working with global and local cross-functional teams and communicating regional evidence needs, risks, and recommendations to global stakeholders.
  • Proven ability to manage CROs, vendors, clinical sites, multiple priorities, timelines, and stakeholders in a matrix environment.
  • Excellent written and verbal communication skills, including preparation and review of clinical, scientific, operational, and regulatory documentation.
  • Clinical research experience in orthopedics, joint replacement, trauma, spine, sports medicine, or other implantable or surgical medical devices.
  • Experience interacting or collaborating with the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), another national joint replacement registry, or a comparable medical device or clinical quality registry.
  • Experience using registry or real-world data to identify evidence gaps, support post-market surveillance, evaluate device performance, or inform clinical, regulatory, reimbursement, or market access strategies.
  • Knowledge of the Australian medical device research environment, including local ethics, governance, regulatory, site, and investigator requirements.
  • Experience supporting regulatory submissions, post-market clinical follow-up, investigator-initiated research, or externally sponsored research for medical devices.
  • Prior matrix leadership or people-management experience.
  • Language: English proficiency required.
  • Travel: Up to 20% domestic and international travel may be required.
  • 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.
  • 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

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