Sr Clinical Development Specialist (Pre-Clinical test)

Job Title: Sr Clinical Development Specialist (Pre-Clinical test)

Pay Rate: $72.52/HR,

Duration: 6 months

Location: Irvine, CA

Our Client is a Global medical device Manufacturer

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We are looking for a Sr Clinical Development Specialist (Pre-Clinical test). Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physician

• s.
  Ensure successful product lifecycle management, from early human use through commercial submiss
• ionDevelop and implement a pre-clinical test strategy and provide guidance to team members on execution strat
• egyProvide scientific rationale for product attributes and pre-clinical test resu
• ltsProvide product and procedural expertise for new product development, as well as introduction training for clinical and site person
• nelDevelop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product developme
• nt.Ensure procedural, medical, and scientific factors are considered during cross-functional product development project team meetin
• gs.Design, review, and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments, and/or clinical evaluation repo
• rtsConsult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements complian
• ce.Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review, and other required interim or final repor
• ts.Analyze data to support clinical trial safety investigations and new product developm
• entOther duties as assigned by leaders

hip
Education and Experie

• nce:Bachelor's Degree in biology or life sciences field, 5 Years experience, Class II and III medical device technologies and/or clinical studies background requ
• iredBachelor's Degree in engineering Prefe
• rredProven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Inte
• rnetProven expertise in MS Office Suite, Adobe, and the ability to operate general office machi
• neryExperience with pre-clinical testing protocols, hospital environments, and sterile techni
• quesData analysis skills, with an understanding of statistical analysis techni
• quesGood communication and organizational sk
• illsExcellent written and verbal communication skills and interpersonal relationship skills, including consultative and relationship management sk
• illsFull knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (
• GCP)Demonstrated problem-solving and critical thinking sk
• illsThorough, conscientious, and results-oriented working s
• tyleTeam orie
• ntedAbility to work in a dynamic work environ
• mentKnowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (G
• CP).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 the environment and prevention of pollution under their span of influence/con
• trolExperience in TMVR and/or fluoroscopic and echocardiographic imaging prefe