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AES CE is an established and rapidly growing renewable energy company headquartered in Salt Lake City, UT. The AES Operations team is looking for a Solar Technician with field experience.
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O Conduct ongoing medical reviews of safety related events (e.g., AEs, DD/DMs) per study SMP. o Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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Conduct ongoing medical reviews of safety related events (e.g., AEs, DD/DMs) per study SMP. Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) and clinical trial databases (e.g., Medidata Rave, Argus) Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or overseeing third party management of committee activities per study SMP and associated Charters.
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Abiomed, part of Johnson & Johnson's MedTech is recruiting for a. Develop, implementation and ongoing management of study-specific Safety Management Plan (SMP) and Case Report Forms (e.g., AE, DD/DM, and Adjudication CRFs) and Charters.
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Experience managing or execution of processes for CEC and DSMB/DMC. Ensure timely and accurate execution of all safety related processes (study-specific) per study Safety Management Plan (SMP) and applicable Charter.
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Event reconciliation between EDC and Quality Assurance/Complaints. Clinical Safety Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
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Is responsible for implementing and executing clinical trial safety activities and responsibilities for the clinical research programs. Minimum of 5 years experience implementing safety processes or clinical research experience including management of safety events (medical devices preferred.
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Abiomed, part of Johnson & Johnson's MedTech is recruiting for a Clinical Safety Specialist , located in Danvers, MA or Remote. The Clinical Safety Specialist is responsible for implementing and executing clinical trial safety activities and responsibilities for the clinical research programs.
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For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $145,000. Job Function Drug & Product Safety Operations. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
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Bachelors Degree required; preferably in nursing or life sciences. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. Management of safety related clinical trial activities for assigned studies.
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AES CE is an established and rapidly growing renewable energy company headquartered in Salt Lake City. The AES Operations team is looking for a seasoned Solar Technician II with field experience, this individual would play a pivotal role in ensuring that AES CE operates the portfolio to standards that exceed industry best-practice.
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Drug & Product Safety Operations. Review of draft informed consent forms (templates and site specific) Review applicable study reports and statistical outputs as needed. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.
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Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
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Contribute to the development and implementation of medical safety program initiatives, process improvements and sound safety practices. Support the review, implementation, and execution of standard operating procedures (SOPs.
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