Medical Device Senior Clinical Research Specialist

  • location: Cambridge, MA
  • type: Permanent
  • salary: $115,000 - $120,000 per year
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job description

Medical Device Senior Clinical Research Specialist

job summary:
Seeking a Medical Device Clinical Research Specialist to help develop procedures and initiate preclinical and clinical testing plans for new diagnostic imaging and image guidance products for our Cambridge, MA Lab.

 
location: Cambridge, Massachusetts
job type: Permanent
salary: $115,000 - 120,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Support development activities, especially the conduct of preclinical and clinical evidence gathering with different vendors and collaborators
  • Responsible for defining, coordinating and performing tasks in preclinical development including protocol development, study conduct, and final reporting
  • Participate in SOP development in support of a growing pre-clinical and clinical evidence function
  • Support and coordinate clinical research activities with external collaboration, including study initiation, scheduled reviews, data and reports management
  • As a core team member, collaborate with multi-functional team members to drive preclinical and clinical development strategies and plans
  • Collect budget and time information from key sites and stakeholders to translate the feedback into executable plans
  • Support clinical trial initiation and co-ordination with collaborating sites, including contract negotiations, site evaluation, protocol updates and edits, and where needed, CRO engagements for monitoring and data management
  • Provides input into clinical evidence documents to ensure alignment with overall business strategy, including: protocols, pre-clinical study reports, clinical study reports, and processes for EUMDR documentation (such as the Post-Market Clinical Follow-Up Plans [PMCF]) and External Research Proposals (ERPs)
 
qualifications:
  • Education required: Minimum Bachelor degree in engineering, life science or related discipline
  • 5+ years of preclinical/clinical development experience in an FDA regulated medical environment
  • Clinical research experience working with CRO's is a plus
  • Basic understanding of biostatistics and clinical trial design. Experience with Minitab is a plus
  • Proven track record of success at guiding preclinical and clinical development efforts
  • Proficient in Microsoft Office suite. Experience with project management and Microsoft Project is a plus
  • Science or engineering post-graduate degree is a plus
 
skills: Clinical research, GLP (Good Laboratory Practice), CRFs, Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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