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Senior Clinical Scientist

Plano, TX, United States

Posted on
Dec 05,2019

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**MEMBERS ONLY**SIGN UP NOW***. is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.Primary Job FunctionProvides scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies. Writes/manages clinical evaluation plans and/or clinical trial protocols, protocol amendments,  clinical reports), clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to assist in clinical strategy, the development of plans and reports, and project deliverables. Interacts with regulatory agencies as needed and will use their scientific and medical knowledge to provide directives to staff as well as study sites as directed by your manager.Core Job Responsibilities:Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.Writes clinical evaluation plans and trial protocols, protocol amendments, informed consents, clinical reports, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.Interprets results of clinical evaluation plans and trial protocols by evaluating clinical, scientific and risk data and literature and staying abreast of current clinical practice.Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager. Participates in clinical trial or clinical evaluation timelines and budgets to ensure expenditures are within budgetary guidelines.Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.Participates in and supports audits.Education and Experience:Bachelor's degree required. Advanced degree highly preferred. Degree in the sciences, medicine, statistics, or related discipline preferred. Minimum of 5 years of related work experience with a substantial understanding of specified functional area, or an equivalent combination of education and work experience.Comprehensive knowledge of a particular technological field, with knowledge and experience in a cardiac-related field preferred.Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.,title:Senior Clinical Scientist,datePosted:2019-12-06T00:00:00.000Z,@context:****& Development} Senior Clinical Scientist job | **MEMBERS ONLY**SIGN UP NOW***. Laboratories United States job in United States - Texas - Plano

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