Siemens Careers

Clinical Affairs Specialist 2 (CRA II)

Norwood, Massachusetts
Quality Management

Apply
English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Point of Care
Requisition Number: 227459
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 40%

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

 

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.




Job Description:

Siemens US Talent Acquisition

Position Overview

 

Do you want to be part of something exceptional? If working for Siemens Healthineers in the Point of Care (POC) Business peaks your interest, then this opportunity is for you!  We are looking for a person with 2-5 years of Clinical Operations experience to join our enthusiastic and collaborative team.

 

The selected individual will:

  • Participate in designing, initiating, monitoring and coordinating in vitro diagnostic studies to collect data to support submissions to regulatory authorities and future product development
  • Help to ensure the successful execution of clinical trials with the goal of adhering to target timelines, budget and quality
  • Report to Director, Pre-Market Clinical & Regulatory Affairs, Quality Technology, Point of Care Business Area

 

Responsibilities

  • Participate in performing clinical trials, which may include protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection / management
  • Independently monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance; occasional handling of biological samples may be required, based upon project need
  • Assist clinical sites with IRB submission / documentation, as needed
  • Utilize a working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
  • Identifies and resolves readily identifiable, clearly-defined problems, while referring semi-complex, unusual problems to others when needed
  • Work cross-functionally with Regulatory Affairs and Quality Management, 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
  • Demonstration of 2-5 years of successful experience in clinical operations and successful performance of responsibilities presented above
  • Experience in in vitro diagnostics and/or the medical device industry
  • Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
  • Demonstration of effective oral communication skills with clinical sites, and internal / external personnel from various departments / levels
  • Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically; <10% internationally

 

Preferred Knowledge/Skills, Education, and Experience

  • CCRA certification with ACRP or SoCRA
  • Medical Technologist or equivalent experience in hospital laboratory setting

#LI-EM1



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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



Can't find what you are looking for?

Let's stay connected