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 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 regulatory submissions and for use in future product development
- Drive the execution of clinical studies while adhering to target timelines, budget, and quality standards
- Report to Director, Clinical Affairs, Quality, Point of Care Business
- Independently 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 conducting cardiac-focused clinical studies
- 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 40% domestically; <20% internationally)
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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