Siemens Clinical Affairs Project Manager - Cardiac Focus in Norwood, Massachusetts
Are you looking to be a part of something exceptional? If working for SiemensHealthineers in the Point of Care Business Area piques your interest, then this opportunity is for you! We are looking for a self-motivated, 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 regulatorysubmissions and for use in future product development
Drive the execution of clinical studies while adheringto target timelines, budget, and quality standards
Report to Director, Clinical Affairs, Quality, Point ofCare Business
Independently managing clinical studies, which mayinclude protocol development including risk rationales and study design, CRFdevelopment, investigational product supply management, budget/contractnegotiation and regulatory document management
Conducting and/or assisting clinical teammates with on-sitevisits, including qualifications through close-outs; training clinical siteson implementation and conduct of study protocols
Monitoring conduct/compliance of clinical studies asrelated to GCP, SOPs, and regulatory requirements, utilizing knowledge ofthe diagnostic area sufficient to perform source data verification; occasionalhandling 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 otherregulatory submissions
Proactively anticipating and identifying issues; implementingsolutions, proposing corrective actions in areas relevant to the role
Cross-functionally assisting other Quality colleagues, RegulatoryAffairs and Quality Systems, as workload permits to support efforts inthese areas
Required Knowledge/Skills, Education, and Experience
BS/BA in life science discipline or equivalentcombination of education and experience; Medical Technologist or similar (MT/MLT)highly preferred
Demonstration of 8-10 years of deep professionalknow-how and successful experience in related field; evidence of successfulperformance of responsibilities presented above
CCRA certification with ACRP or SoCRA
Experience with invitro diagnostics and/or medical device industry
Experience conducting cardiac-focused clinical studies
Experience with Pre-Subs and 510k submissions
Demonstration of strong writing skills in all jobresponsibilities ( e.g. protocols,monitoring reports, correspondence, clinical study reports, etc.)
Demonstration of effective oral communication skillswith clinical sites, and internal/external personnel from variousdepartments/levels
Ability and willingness to travel, depending uponproject need (occasionally up to 40% domestically; <20% internationally)
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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