6 days old

Clinical Affairs Specialist 3 (Senior CRA)

Norwood, MA
**Clinical Affairs Specialist 3 (Senior CRA)**

Locations:Norwood, Massachusetts

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Point of Care

**Requisition Number:** 218482

**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:**

Siemens is a global technology powerhouse that

has stood for engineering excellence, innovation, quality, reliability and

internationality for more than 165 years. As a global technology company,

Siemens is rigorously leveraging the advantages that this setup provides. To

tap business opportunities in both new and established markets, the Company is

organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy

Management, Building Technologies, Mobility, Digital Factory, Process

Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens

Healthineers is one of the worlds largest suppliers of technology to the

healthcare industry and a leader in medical imaging, laboratory diagnostics and

healthcare IT. All supported by a comprehensive portfolio of clinical

consulting, training, and services available across the globe and tailored to

customers needs. So that more people can have a life that is longer, richer,

and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthineers

**Job Description:**

**Siemens US Talent Acquisition**

**Regulatory Clinical Affairs Specialist 3**

**Position Overview**

**_Are you looking to be a part of something exceptional? If working for_** **_Siemens Healthineers in the Point of Care (POC) Business Area_** **_peaks your interest, then this opportunity is for you!_** We are looking for **_a person experienced in Clinical Affairs (_** **_i.e._** **_Clinical Operations) to join our enthusiastic and collaborative team._**

**_The selected individual will:_**

+ Initiate, design and coordinate _in vitro_ diagnostic studies to collect data to support submissions to regulatory authorities and future product development

+ Take responsibility of ensuring the 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


+ Manage clinical trials, which may include protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection / management

+ 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

+ Anticipate and identify problems / issues and implement resolutions or provide recommendations for corrective actions in relevant job areas

+ 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 **5-8 years** of successful experience in related field and successful performance of responsibilities presented above

+ CCRA certification with ACRP or SoCRA

+ 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**

+ Medical Technologist or equivalent ( _hospital_ ) laboratory background

+ Experience with Pre-Subs and 510k submissions


**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 .


  • Engineering
  • Financial Services
  • Healthcare

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Clinical Affairs Specialist 3 (Senior CRA)

Norwood, MA

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Norwood, MA

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