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Siemens Senior Clinical Research Associate – Cardiac Focus in Norwood, Massachusetts

Senior Clinical Research Associate – Cardiac Focus

  • Norwood, Massachusetts

  • Quality Management

  • 247110

Siemens Healthineers

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Job Description

Organization: Siemens Healthineers

Business Unit: Point of Care

Requisition Number: 247110

Primary Location: United States-Massachusetts-Norwood

Assignment Category: Full-time regular

Experience Level: Mid level

Education Required Level: Bachelor's Degree

Travel Required: 10%

Job Description:

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 foran experienced Clinical Affairs ( i.e. clinical operations) professional to join our enthusiastic and collaborative team.

The selected individual will:

  • Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatorysubmissions and for use in future product development

  • Take responsibility of ensuring the execution ofclinical studies with the goal of adhering to target timelines, budget andquality

  • Report to Director, Clinical Affairs, Quality, Point ofCare Business Area

Responsibilities

  • Managing clinical studies independently, 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

  • Assisting in the preparation of the clinical portion ofPre-Subs, 510ks and other regulatory submissions

  • Anticipating and identifying issues; implementing solutions,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

  • CCRA certification with ACRP or SoCRA

  • Demonstration of 5-8 years of professional know-how andexperience in Clinical Affairs; evidence of successful performance ofresponsibilities presented above

  • Experience with invitro diagnostics and/or medical device industry

  • Experience conducting cardiac-focused clinical studies

  • 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; 10-20% internationally)

Preferred Knowledge/Skills, Education, and Experience

  • MedicalTechnologist or similar (MT/MLT) highly preferred

  • Experience with Pre-Subs and 510k submissions

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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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, 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/ofccp/pdf/pay-transp_formattedESQA508c.pdf .

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