Job Opening for Clinical Operations Manager in Alveo Technologies (Alameda, CA)

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Job Category : Management
Company Name: Alveo Technologies
Position Name: Clinical Operations Manager
Location : Alameda, CA
Job Description : About AlveoAlveo is leading the transformation of the consumer health tech market with a low-cost, easy-to-use, at-home diagnostic platform that will change the way infectious diseases are detected and managed. The company’s be.well™ testing system gives individuals access to cutting-edge molecular testing and cloud-based data analytics for rapid diagnosis and management of infectious diseases. With an initial focus on acute respiratory infections, including COVID-19, Influenza A/B, and RSV, Alveo’s agile and dynamic diagnosis platform can be adapted to detect a wide range of diseases that threaten public health. Affordable access to real-time, at-home results will transform the way individuals, healthcare providers and public health professionals identify and manage disease outbreaks. With be.well™, we will Know Sooner, Act Faster™ and make better-informed decisions toward personalized intervention options that benefit individuals and the entire population. To learn more, visit https://alveotechnologies.com/Alveo is seeking a Clinical Operations Manager who will responsible for assisting with clinical trial management, site management, and data review while ensuring the trial is conducting in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/work instructions.You Will: Be responsible for multiple large clinical studies, or several related studies including setting up sites worldwideAct as Clinical studies representative to project core teamsInteract as the primary interface between the company and CRO to ensure CRO activities and timelines are in coordination with regulatory and project requirementsConduct standard pre-study; initiation; interim; and close-out monitoring visits and completes site visit reportsEnsure site compliance with regulations and study protocolIdentify and qualify clinical investigators and clinical sitesPrepare clinical study documentsPropose and negotiate budgets for clinical studies. Initiates payment to sitesObtain and review all required essential documents necessary for study initiationReview and monitor clinical data generated by diagnostic IVD instrumentsPrepare and present clinical data reviews and data summariesMaintain accurate and timely sponsor/site correspondence and communication.Prepare and present project progress reports to keep management and team informedEnsure compliance with Good Clinical Practices, regulations, SOPs, and protocolsAcquire and maintains technical knowledge of product line(s)Mentor/train/manage junior level CRA personnel**Your Background Should Include: Minimum of 8 years clinical experience directly with IVD products; CRO oversight experience a plusExceptional documentation skills, preferably in the FDA regulated industryExperience managing and mentoring a small teamExcellent verbal and written communication with all leadership levels and external sites/investigatorsMust be accountable for own tasks and a team player willing to support others when neededMust be familiar and have experience with clinical regulations and standards affecting IVDsMinimum Bachelor’s degree in biological sciences or medical specialty preferredUp to 30% travel may be neededWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Job Type: Full-time
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