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Jobs - Association of Medical Diagnostics Manufacturers About Board Scholarships Members Join 2018 Focus Meeting Education Roundtables Past Presentations RA/QA Topics Links Networking Jobs Contact Store Association of Medical Diagnostics Manufacturers Job Postings AMDM posts unshut positions within the IVD Industry.  The charges for a 60-day posting for AMDM Members are $150 (Join AMDM), and $300 for Non-Members.  A unstipulated notice of a new posting to the AMDM database is moreover included.To post your unshut position, please send your job unravelment with contact information to amdm_secretary@att.net.  Jobs will be published on this page within 48 hours and a notice sent to the AMDM database alerting them to the new posting. An invoice will be emailed. Senior ClinicalWiresSpecialist, Hycor Biomedical, LLC - posted 7 10.18This position has a leading role in the planning, coordination, and execution of Hycor’s clinical performance studies.  She/he must have spanking-new verbal and written liaison skills, have the worthiness to motivate and manage teams and have in vitro diagnostic (IVD) technical clinical research operational skills.  The Senior ClinicalWiresSpecialist must have an spanking-new working knowledge of workable regulations and guidelines. The Senior ClinicalWiresSpecialist, through individual contribution and with the support of his/her team will:Manage the overall day-to-day operations of multiple IVD clinical performance studies. Coordinate and prepare Clinical Investigational Plans/Protocols and supporting clinical study materials.Develop and manage clinical study plans and budgets and is responsible for monitoring and achieving targets.  Conducts routine and ad hoc meetings and written updates, with clinical affairs, cross-functional teams and visitor leadership to momentum projects and share key information. Manage study budgets and accounting. Ensure constructive and efficient study initiation through procedures and weightier practices in site qualification and development.    Ensure timely trial progress including site management for constructive subject recruitment and protocol compliance.  Ensure clinical data integrity is maintained through towardly oversight of staff, sites and monitoring practices through all phases of the studies.Manage medical monitoring processes, core-labs, and other contracted study vendors.  Liaise with study committees, such as Steering and Data Monitoring Committees, as needed.Have a detailed knowledge of GCPs, ISO 14155, and EN 13612.Assist in preparation of Clinical Reports for regulatory submissions, including 510(k)s, international pre-market submissions, and Clinical Reports for other data dissemination activities.Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff, including qualification, selection, budget, and work-scope negotiations and oversight.Support and establish procedures and work instructions for key clinical research activities to reassure compliance and efficient study conduct.·         Coordinate and prepare clinical study reports and summaries on clinical trial results for internal review by other departments and senior staff.  When appropriate, supports the preparation of manuscripts for publication of trial results in professional journals.Create, manage and oversee the maintenance of all trial master files, at visitor and at investigational sites. Be prepared for and manage on-site or remote regulatory audits by visitor or regulatory organ representatives. Support visitor goals and objectives, policies and procedures, performance management programs, and workable national and local regulations. Act as cadre team member on project teams to provide clinical trial guidance and strategic clinical trial planning in support of new product minutiae and existing product support.Participate in and review risk management activities/documents and ensure compliance with ISO 14971.Work directly with medical wires and complaint handling staff to facilitate well-judged wrongheaded event reporting. Maintain a “big picture” perspective, taking personal responsibility for deportment and maintaining a transferral to quality and integrity.Support commercialization activities for product lines globally equal to local and regional regulatory and quality requirements.Lead projects of various telescopic and size, as assigned.Be experienced in influencing other functions and managing in a matrix environment.  Perform other duties, as required or assigned.Have strong planning, organizational, and liaison skills.Have computer knowledge consisting of email, Word, Excel, Project, Visio, Adobe Acrobat Professional, and other vital skills.Have spanking-new judgment, a positive suburbanite attitude, be consumer oriented, and a team player.Education: Bachelor Degree in Science or Medical Technology.Licenses/Certifications: Clinical Research Associate Certification (CCRA and/or CCRP) is a plus.Skills/Abilities:Worthinessto work independently. Spanking-neworal, written, organizational, and tampering skills.  Solid understanding of IVD products, immunoassays, IVD instruments and software, and unstipulated clinical lab materials and supplies. Worthinessto represent the clinical department in frequent inter-organizational meetings. Worthinessto perform work with minimal direction and supervision. Worthinessto provide solutions to difficult technical issues associated with specific projects.Experience:Minimum of 7 years of wits in diagnostics, life science, or medical devices with a minimum of 5 years in clinical research and 2 years of IVD specific clinical research.  IVD reconnaissance minutiae wits is a plus.Demonstrated worthiness to successfully manage and execute clinical studies with IVDs to meet merchantry goals using standard weightier practices and compliance norms.Demonstrated worthiness to supervise CRAs and Monitors, and work successfully on cross-functional teams. Detailed knowledge of GCPs, ISO 14155, and EN 13612.Working knowledge of IDEs, 510(k)s, and IVDD/IVDR. Working knowledge of ISO 13485, Quality System Regulation, and relevant international standards.Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971.Proven track record of maintaining clinical knowledge and skills by participating in industry conferences/seminars.Must be misogynist and willing to work flexible schedules, as needed.Must be worldly-wise to travel, up to 30%.  Preferred Experience/Skills:Prior wits with GCP and internal audits.Strong working knowledge of problem solving and statistical methods, as unromantic to clinical studies.Good understanding of medical treatment aspects related to IVDs for allergies and auto-immune diseases.Ability to read, analyze, and interpret unstipulated merchantry periodicals, professional journals, technical procedures, or regulations.Worthinessto independently determine and develop tideway to a wide range of issues and problems. Solutions must be thorough, practical, and resulting with organization objectives. Please send resumes to LCristobal@hycorbiomedical.com or wield by clicking on the pursuit link: https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=aa4f5f5e-5cc7-4acb-a719-7a0e61d841e8&jobId=253792&lang=en_US&source=CC3&ccId=2498089904_10388Clinical Research Associate, Hycor Biomedical, LLC - posted 7 10.18This position has a supporting role in the planning, coordination, and execution of Hycor’s clinical performance studies.  She/he must have spanking-new organizational skills, spanking-new verbal and written liaison skills, have the worthiness to motivate and support teams and have in vitro diagnostic (IVD) technical skills and/or clinical research operational skills.  The Clinical Research Associate must have knowledge of workable regulations and guidelines.​The Clinical Research Associate, through individual contribution will:·         Support the overall day-to-day operations of multiple IVD clinical performance studies. ·         Assist in the minutiae and management of Clinical Investigational Plans/Protocols and supporting clinical study materials.·         Conducts routine and ad hoc meetings and written updates, with clinical affairs, cross-functional teams and visitor leadership to help momentum projects and share key information. ·         Support constructive and efficient study initiation through procedures and weightier practices in site qualification and development.    ·         Support timely trial progress including site management for constructive subject recruitment and protocol compliance.  ·         Support clinical data integrity by monitoring practices through all phases of the studies.·         Liaise with core-labs, contracted study vendors, and study committees, such as Steering and Data Monitoring Committees, as needed.·         Have a good knowledge of GCPs, ISO 14155, and EN 13612.·         Assist in preparation of Clinical Reports for regulatory submissions, including 510(k)s, international pre-market submissions, and Clinical Reports for other data dissemination activities.·         Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff, including qualification, selection, budget, and work-scope negotiations and oversight.·         Support minutiae of and trueness to procedures and work instructions for key clinical research activities to ensure compliance and efficient study conduct.·         Coordinate and support the preparation of clinical study reports and summaries on clinical trial results for internal review by other departments and senior staff.  When appropriate, supports the preparation of manuscripts for publication of trial results in professional journals.·         Create, manage and oversee the maintenance of all trial master files, at visitor and at investigational sites. ·         Be prepared for and manage on-site or remote regulatory audits by visitor or regulatory organ representatives. ·         Support visitor goals and objectives, policies and procedures, performance management programs, and workable national and local regulations. ·         Act as a team member on project teams to provide clinical guidance in support of new product minutiae and existing product support.·         Participate in and review risk management activities/documents and ensure compliance with ISO 14971.·         Work directly with medical wires and complaint handling staff to facilitate well-judged wrongheaded event reporting. ·         Maintain a “big picture” perspective, taking personal responsibility for deportment and maintaining a transferral to quality and integrity.·         Support commercialization activities for product lines globally, equal to local and regional regulatory and quality requirements.·         Lead projects of various telescopic and size, as assigned.  ·         Perform other duties, as required or assigned.·         Have strong planning, organizational, and liaison skills.·         Have computer knowledge consisting of email, Word, Excel, Project, Visio, Adobe Acrobat Professional, and other vital skills.·         Have spanking-new judgment, a positive suburbanite attitude, be consumer oriented, and a team player.Education: Bachelor Degree in Science or Medical TechnologyLicenses/Certifications: Clinical Research Associate Certification (CCRA and/or CCRP) is a plus.Skills/Abilities:Worthinessto work independently. Spanking-neworal, written, organizational, and tampering skills.  Good understanding of IVD products, immunoassays, IVD instruments and software, and unstipulated clinical lab materials and supplies. Worthinessto represent the clinical department in frequent inter-organizational meetings. Worthinessto perform work with minimal direction and supervision. Worthinessto provide solutions to difficult technical issues associated with specific projects.Experience:·         Minimum of 5 years of wits in diagnostics, life science, or medical devices with a minimum of 2 years in clinical research and, ideally, at least 1 year of IVD specific clinical research.  IVD reconnaissance minutiae wits is a plus.·         Demonstrated worthiness to successfully support clinical studies to meet merchantry goals using standard weightier practices and compliance norms.·         Demonstrated worthiness to work successfully on cross-functional teams. ·         Good knowledge of GCPs, ISO 14155, and EN 13612.·         Working knowledge of IDEs, 510(k)s, and IVDD/IVDR. ·         Working knowledge of ISO 13485, Quality System Regulation, and relevant international standards.·         Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971.·         Proven track record of maintaining clinical knowledge and skills by participating in industry conferences/seminars.·         Must be misogynist and willing to work flexible schedules, as needed.·         Must be worldly-wise to travel, up to 30%. Preferred Experience/Skills:·     Prior wits with GCP and internal audits.·     Strong working knowledge of problem solving and statistical methods, as unromantic to clinical studies.·     Good understanding of medical treatment aspects related to IVDs for allergies and auto-immune diseases.·     Ability to read, analyze, and interpret unstipulated merchantry periodicals, professional journals, technical procedures, or regulations. ·      Ability to independently determine and develop tideway to a wide range of issues and problems. Solutions must be thorough, practical, and resulting with organization objectives.Please send resumes to LCristobal@hycorbiomedical.com or wield by clicking on the pursuit link:https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=aa4f5f5e-5cc7-4acb-a719-7a0e61d841e8&jobId=253772&lang=en_US&source=CC3&ccId=2498089904_10388 Copyright © 2011 AMDM, 555 Thirteenth Street, NW Washington, D.C. 20004 Contact   About   Join   Store   Privacy Policy