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Clinical Systems Specialist

Date:  May 21, 2021
Location: 

Danvers, MA, US

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

The Clinical Systems Specialist (CSS) is responsible for the continued development, maintenance, optimization and support of technologies that drive clinical trial execution.   She/he will also contribute to initiatives to identify and implement new clinical technologies.  The CSS will ensure the clinical applications enable business process, drive efficiency, promote best practice among the end user community, and comply with federal/international regulations and internal IT policies and procedures. She/he will work closely with Clinical Program Managers, Clinical Trial Coordinators, Clinical Data Managers, Privacy and IT functions to ensure compliant clinical trial systems to support clinical trials.

 

Principle Duties and Responsibilities:

  • Leads/Support the development, maintenance, optimization and support of one or more clinical applications.
  • Collaborates with identified stakeholders to identify user requirements and subsequently implement solutions to promote efficiency, compliance and best practice. 
  • Author/Support the creation and review of departmental SOPs, Work Instructions, and training materials.
  • Ensures that the design and use of clinical applications adheres to applicable regulations, standards, policies and procedures.
  • Engages, defines, and drives the implementation of new technologies and/or enhancements to existing applications with external vendors.
  • Stays abreast of new technologies and/or enhancements to existing applications; informs and collaborates with stakeholders to assess the impact on business process.
  • Collaborates and/or Leads training of end user community on new and/or existing technologies, ensuring business stakeholders have the knowledge to leverage the technology to its full capacity.

Job Qualifications:

  • Bachelor’s degree from an accredited university required; BS preferred in Life Sciences, Computer Sciences, Data Science/Analytics, Mathematics, or related medical/scientific/technical field.
  • Minimum 2 years of clinical system administration required.
  • Minimum 1 years of experience with system of specialization.  System(s) of specialization may include:
    • Medidata platform administration (Cloud Administration, EDC, CTMS, TSDV and Imaging).
    • Veeva Vault eTMF administration.
  • Minimum 2 years of professional experience in a functional capacity in a CRO, pharmaceutical, biotechnology, or medical device company; Clinical Monitoring, Project Management, or Data Management preferred.
  • Knowledge of computer system validation (CSV) lifecycle management and associated documentation required.
  • Knowledge of data privacy including European General Data Protection Regulation (GDPR) desired.
  • Working knowledge of clinical trial operations desired.
  • Experience with JReview and Business Objects desired.
  • Intermediate knowledge of SQL, CSharp (C#), and other programming languages required.
  • CRO/vendor management experience desired.
  • An equivalent combination of education, experience and performance may be considered.

 

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.


Nearest Major Market: Boston