Clinical Affairs Project Manager – Cardiac Focus

Job Description

Position Overview

Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business Area piques 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 senior professional will:

  • Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions and for use in future product development
  • Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget and quality
  • Report to Director, Clinical Affairs, Quality, Point of Care Business Area

Responsibilities

  • Managing clinical studies, which may include protocol development including risk rationales and study design, CRF development, investigational product supply management, budget/contract negotiation and regulatory document management
  • Conducting and/or assisting clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols
  • Monitoring conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling 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 other regulatory submissions
  • Proactively anticipating and identifying issues; implementing solutions, proposing corrective actions in areas relevant to the role
  • Cross-functionally assisting other Quality colleagues, Regulatory Affairs and Quality Systems, 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; Medical Technologist or similar (MT/MLT) highly preferred
  • Demonstration of 8-10 years of deep professional know-how and successful experience in related field; evidence of successful performance of responsibilities presented above
  • CCRA certification with ACRP or SoCRA
  • Experience with in vitro 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 job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical study reports, etc.)
  • Demonstration of effective oral communication skills with clinical sites, and internal/external personnel from various departments/levels
  • Ability and willingness to travel, depending upon project need (occasionally up to 40% domestically; <20% internationally)

#LI-EM1


Job ID: 180512

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, 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

Can't find what you are looking for?