Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business Area piques your interest, then this opportunity is for you! We are looking for an experienced clinical operations leader to join our enthusiastic and collaborative team. The selected senior professional will: Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions and for use in future product development Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget and quality Report to Director, Clinical Affairs, Quality, Point of Care Business Area Responsibilities Managing clinical studies, which may include protocol development including risk rationales and study design, CRF development, investigational product supply management, budget/contract negotiation and regulatory document management Conducting and/or assisting clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols Monitoring conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling of biological samples may be required, based upon project need Assisting clinical sites with IRB submission/documentation, as needed Preparing the clinical portion of Pre-Subs, 510ks and other regulatory submissions Proactively anticipating and identifying issues; implementing solutions, proposing corrective actions in areas relevant to the role Cross-functionally assisting other Quality colleagues, Regulatory Affairs and Quality Systems, as workload permits to support efforts in these areas Required Knowledge/Skills, Education, and Experience BS/BA in life science discipline or equivalent combination of education and experience; Medical Technologist or similar (MT/MLT) highly preferred Demonstration of 8-10 years of deep professional know-how and successful experience in related field; evidence of successful performance of responsibilities presented above CCRA certification with ACRP or SoCRA Experience with in vitro diagnostics and/or medical device industry Experience with Pre-Subs and 510k submissions Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical study reports, etc.) Demonstration of effective oral communication skills with clinical sites, and internal/external personnel from various departments/levels Ability and willingness to travel, depending upon project need (occasionally up to 25% domestically; <5% internationally) Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law. (Note: Accommodations may be requested for certain medical or religious reasons) #LI-EM1 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Experienced Professional Full / Part time: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Pay Transparency Non-Discrimination Provision Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here. California Privacy Notice California residents have the right to receive additional notices about their personal information. To learn more, click here.