Massachusetts Green Jobs

Position Overview

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

Responsibilities

• 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)

#LI-EM1

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 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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf .

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