15 Oct
|
Johnson & Johnson
|
Sydney
15 Oct
Johnson & Johnson
Sydney
At Johnson 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 *****, 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, adaptable, and accessible working arrangements for all.
Johnson
📌 Manager, Clinical Research (Sydney)
🏢 Johnson & Johnson
📍 Sydney