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Principal Clinical Research Scientist

Date:  Nov 22, 2022
Location: 

Danvers, Massachusetts, 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, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 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
 

Job Responsibilities:

We are looking for a strong leader to support the development and design of Abiomed’s global clinical studies with the focus on sound clinical evidence generation in order to drive better patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will oversee the clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products.

 

Primary Duties and Responsibilities:

  • Execute on Abiomed’s scientific objectives within Abiomed sponsored clinical studies
  • Serve as Scientific Lead on Abiomed sponsored clinical studies
  • Own protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators
  • Be the point person for scientific questions during execution of these clinical studies
  • Responsible for scientific content for all trial related documents
  • Own annual and final report content development, coordination of content from various stakeholders.
  • Execute publication/presentation charter development for clinical studies
  • Support the production of trial-related interim analyses, hypothesis testing, publications and presentations
  • Own Steering committee meetings and Scientific lead on Investigator/Research coordinator meetings
  • Develop maintain and review periodical study reports. Review for outliers, ranges, potentially problematic data, identify and communicate root causes from input error to inadequate field edits, and suggest possible solutions, thereby documents data observations, and follow pre-established processes and procedures
  • Execute on the regulatory pathway required for new investigational devices and for indication expansion globally
  • Conduct literature review and clinical data to support regulatory submissions and CERs
  • Cross-collaboration with Medical Office departments
  • Ensure data analysis integrity for clinical studies within scope of role

Job Qualifications:

  • PhD or MD required
  • At least 3 years of Clinical Science/Research experience in Cardiology/Cardiovascular space or Clinical Science/Research experience in Med Devices
  • Med Device Clinical Research experience strongly preferred
  • Experience with scientific contribution to large multicenter clinical trials required
  • Proficiency in Med terminology, medical writing, experience with following ICMJE guidelines
  • Strong understanding of Biostatistics; ability to use statistical programs such as Matlab, SAS a strong plus
  • Demonstrated publications is high impact factor peer-reviewed journals
  • Knowledge of healthcare ethics, compliance regulations
  • Advanced knowledge of MS Office, Adobe suite
  • Strong work ethics, self motivation, team player, excellent English written and oral communication skills and strong interpersonal skills

 

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. Abiomed maintains a drug-free workplace.