Siemens Financial Services Inc.
The Clinical Affairs Specialist is responsible for devisingand executing strategies for clinical trials of Molecular In-Vitro Diagnosticsproducts. The clinical trials will be used to support Pre-Market Approvals(PMA) or 510(k)s in the United States or the IVDD and/or the IVDR in the EU fornew or existing products. These trials are complex, usually consisting ofseveral sub-studies and multiple clinical sites.Responsibilities include representing clinical affairs instrategic projects, oversight of the timely execution and compliance ofclinical trials, and preparation of regulatory submissions. The role requires monitoring of proposedregulations and guidance documents related to clinical trials and ensuring thatall clinical activities remain compliant with these requirements. Theindividual will interact with regulatory bodies to present clinical plans orclinical data in support of product approvals. He/she will interface withPrincipal Investigators to execute contracts so that clinical trials areperformed within the required time frame. Ideally, the candidate should have an M.S. or Ph.D. in an area of lifescience, with a minimum of 10 years of experience in the area of clinical trialsand expertise in infectious diseases. The candidate will collaborate with other teams internationally tosuccessfully deliver multiple PMA and 510(k) submissions simultaneously. The role reports to the Head of Quality andTechnology and is located in Berkeley, California. Educationand Experience\u00b7 An M.S. orPh.D , preferablyin areas of life science, engineering or equivalent\u00b7 10 years of experience in clinical trials andregulatory submissions (PMA and 510k), supporting new product launches as wellas product updates in the IVD or Molecular Diagnostics field\u00b7 5 years of leadership experience, with proventrack record of delivering projects on time and promoting high performancebehaviors within a team\u00b7 Familiarity with international regulations forIVD Clinical Trials and prior experience in the acquisition and management ofclinical trial samples\u00b7 Prior experience working with cross-functionalproject teams, IRBs and business partners \u00b7 Fluency with Microsoft Office and MicrosoftOutlook Required Knowledge/Skills\u00b7 Agile and flexible team player with the abilityto meet project timelines and complete clinical affairs deliverables to meetglobal regulatory requirements related to clinical trials\u00b7 Understanding of regulations and guidelinesgoverning the areas of medical device and in-vitro diagnostic development, witha broad knowledge of requirements and best practices in Clinical Affairs,Regulatory Affairs and Product Development\u00b7 Proven ability to multitask, collaborate incross-functional teams, and work independently\u00b7 Excellent communication skills and workingknowledge of English grammar, punctuation and overall writing skills, with theability write clinical trial reports and documentation independently\u00b7 Critical-thinker with excellent negotiationskills and the ability to address complex situations independently, and theability to adopt a systemic view of continuous process improvement to supportbusiness goals and decisions\u00b7 Proven ability to manage multiple time-sensitivehigh priority projects \u00b7 Ability to develop or revise clinical trialprocedures and processes\u00b7 Willingness to travel up to 30% Preferred Knowledge/Skills, Education, andExperience\u00b7 Key Opinion Leader with subject matter expertisein infectious diseases \u00b7 Excellent relationships with a broad base ofclinicians and laboratorians who can perform field or clinical trials and whohave clinical populations appropriate for specimen acquisition \u00b7 Direct Laboratory experience \u00b7Professional designations are not required, but training and certificatesin quality or regulatory affairs is a plus (e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma,Lean Principles)
Siemens Financial Services Inc.
Website : http://www.siemens.com
Siemens is a global powerhouse focusing on the areas of electrification, automation and digitalization. One of the world’s largest producers of energy-efficient, resource-saving technologies, Siemens is a leading supplier of systems for power generation and transmission as well as medical diagnosis. In infrastructure and industry solutions the company plays a pioneering role. As of September 30, 2015, we had around 348,000 employees in more than 200 countries. In fiscal 2015, they generated revenues of €75.6 billion.