Siemens Clinical Affairs Specialist in Norwood, Massachusetts
Clinical Affairs Specialist
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Point of Care
Requisition Number: 211049
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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 world’s 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
Siemens US Talent Acquisition
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 an experienced clinical operations leader 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
Independently manage 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
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
MT/MLT or equivalent
Experience with clinical trials involving hemostasis and/or urinalysis analyzers
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 .