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ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our smART+™ platform is an intelligent, sensor-based feeding system for critical care patients that aims to prevent life-threatening in-hospital complications such as ventilator-associated pneumonia, malnutrition and acute kidney injury. With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the smART+™ platform monitors, analyzes and prevents malnutrition and gastric aspiration in real-time. By providing optimal nutritional care and achieving up to 100% feeding efficiency, the smART+™ platform improves the standard of care and helps ICU patients recover faster. As a Clinical Application Specialist, you will work collaboratively with field sales, project management, and field service to provide clinical expertise during pre-sale, installation, and post-sale activities. The objective is to achieve a mutually beneficial relationship with physicians, site staff, key administration and other personnel, as well as hospital executives, in order to grow and develop sales and outreach. The Clinical Application Specialist will:
* Lead and assist in developing training materials.
* Provide on-site and /or remote guidance and support, including pre/post/OJT education, in regard to clinical, technical, operational, and effective and optimal usage of our system to hospital staff.
* Support the hospital staff in adapting their workflow and standard of care to meet the new functionality of our system
* Document voice-of-the-customer and post-marketing feedback to product management in order to improve the product: human factors, usability, and functionality, per regulatory requirements and company SOPs.

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Student to join the system team. Job Description: • Analyze and manage risk analysis and assurance case reports for various company products • Serve as risk analysis focal point across the organization • Develop algorithms for various system components • Design and implement experiments for various projects • Participate in departmental tasks that include problem solving and critical/root cause analysis

Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Job Overview:
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions:
Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred our customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

ART MEDICAL is a well-funded medical startup, developing cutting-edge technologies and products for the treatment of ICU patients. Our smART+™ platform is an intelligent, multi sensor-based enteral feeding system for the treatment in critical care patients, that aims to prevent life-threatening complications, and helps ICU patients recover faster and better. We are looking for an experienced, highly motivated and talented Project Manager to join us. If you are a self driven, team player, have a can-do and problem-solving attitude, and want to impact the future of patient care in the ICU, then you may be the person we are looking for! As a Project Manager at ART, you will be responsible for leading, managing, and executing multi-disciplinary projects plans and activities in compliance with Medical Device 13485 standards. The primary objective is to effectively achieve planned specifications, quality standards, timelines, and budgetary constraints and to continually improve the lifecycle management process. You will be responsible for highlighting needs to assure technical proficiency and quality deliverables. We offer a collaborative, multi-disciplinary workplace, a chance to learn with and from interesting and enthusiastic colleagues. A rapidly growing, working environment and growth opportunities.