Job details
Job type full-time
Full job description
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.gProtocols, 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 continuityGoing 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)
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Organization: siemens healthineers
Company: siemens healthcare diagnostics inc.
Experience level: experienced professional
Job type: full-time
Equal employment opportunity statement
Siemens is an equal opportunity and affirmative action employer encouraging diversity in the workplaceAll 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.
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