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Project Manager Medical Devices jobs

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    • Project Manager is responsible for the overall project deliverables, leading the internal team and the financial performance of the project.
    • View all Novotech jobs - Australia jobs - Project Manager jobs in Australia
    • Salary Search: Project Manager - AU salaries in Australia
    • It involves overseeing change management, driving outcomes through a strong relationship with the vendor, coordinating with key stakeholders, and applying…
    • OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level.
    • Our Senior Project Managers are insanely talented and driven to manage large-scale, interactive projects from conception and design to development and…
    • Creates and uses project plans for assigned projects, which include clear milestones and assignment of project task responsibilities.
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    • Adherence to project management processes and governance.
    • Cost, schedule, quality, and technology for the life cycle of the project and potentially across…
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    • Real fluency with medical device regulation: FDA SaMD classification and 510(k)/De Novo pathways, TGA registration, MHRA review, ISO 13485, ISO 14971, IEC 62304…
    • 5+ years as a project manager.
    • Facilitate development of recommended project control solutions to be used for planning, scheduling, and tracking projects…
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    • We also welcome applications from experienced Clinical Research Associates who have recently transitioned into project management and have at least 12 months of…
    • You will be someone who has excellent communication skills and strong commitment to improvement and project work resulting in excellent patient outcomes.
    • Exposure to regulated industries such as pharmaceuticals, healthcare, medical devices, or similarly complex manufacturing environments.
    • Adherence to project management processes and governance.
    • Cost, schedule, quality, and technology for the life cycle of the project and potentially across…
    • Other projects within the remit of Capital and Infrastructure.
    • The role will be responsible for all FFE planning from the conception of the project to the end…
    • Tracking project performance and providing regular updates to stakeholders.
    • Monitoring project risks, identifying mitigation strategies and resolving roadblocks…
    • Familiarity with TGA medical device requirements and post-market obligations.
    • Background in medical devices, digital health, SaMD, biotechnology or related…

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Job Post Details

Project Manager - AU - job post

Novotech
2.9 out of 5 stars
Australia
Full-time
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Job details

Job type

  • Full-time

Location

Australia

Full job description

The Project Manager is primarily responsible for the planning and management of all contracted responsibilities for assigned projects. Act as primary contact between Novotech and client. Leads and oversees the execution of clinical projects in accordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and the Project Agreement to deliver the project on time and to budget. Project Manager is responsible for the overall project deliverables, leading the internal team and the financial performance of the project.

Project Managers are responsible for the delivery of the project from site selection through to Close out of the study including all deliverables within scope. The Project Manager is responsible to identify and evaluate potential risks and develop risk management plans to mitigate this risk.

Project Managers are expected to have a solid understanding of the drug development and clinical trial process, the role and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements.

PMs are expected to contribute to process improvement initiatives.

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