Senior Analyst, Clinical Core Labs (Irvine, CA) THV

Edwards Lifesciences


Job Description
**Senior Analyst, Clinical Core Labs, THV**This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwardss leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.The Senior Analyst, Clinical Core Labs will perform Clinical Operations analytics and ensure deliverables are completed.**Essential Job Functions/Key Responsibilities:**+ Develop and execute device processes associated with clinical trials. Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders (e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.+ Develop timeline assessment (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.+ Identify technical and data issues, perform root cause analysis to determine the cause, provide recommendations, and implement corrective actions, while collaborating with team members+ Lead the validation of systems to incorporate the use of clinical system into clinical studies and act as a liaison to ensure adherence to procedures in collaboration with internal (e.g., Study Management) and external (e.g., vendors) stakeholders+ Other duties as assigned (e.g. audit support)**Minimum Requirements:**+ Bachelor's Degree in in related field+ 5 years previous related experience in clinical operations**Additional Talents and General Expectations:**+ Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel+ Excellent written and verbal communication skills including customer negotiating and relationship management skills+ Excellent problem-solving, organizational, analytical and critical thinking skills+ Full knowledge and understanding of Edwards policies, procedures and guidelines relevant to clinical operations+ Full knowledge of clinical systems+ Good leadership skills and ability to influence change+ Strict attention to detail+ Ability to interact professionally with all organizational levels+ Ability to manage competing priorities in a fast-paced environment+ Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Industry