Medical Device Senior Clinical Research Specialist - 1

  • Free
  • Published date: November 2, 2020
    • Massachusetts, United States



Medical Device Senior Clinical Research Specialist - 1

Cambridge, MA 02139

OVERVIEW




Canon USA’s Healthcare Optics Research Lab is working with leading medical institutions in the Boston area to develop medical imaging technologies. The Medical Device Senior Clinical Research Specialist (Sr Specialist Clinical Research) is part of Research and Clinical Translation team responsible for preclinical and clinical activities from research to product development. It is a hands-on role developing procedures and initiating preclinical and clinical testing plans for new diagnostic imaging and image guidance products.


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:
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

The company will not pursue or support visa sponsorship for this position.

Required Knowledge, Skills, and Abilities: (Submission Summary):

1. Bachelor’s Degree

2. Clinical research experience working with CRO’s is a plus

3. Basic understanding of biostatistics and clinical trial design

4. Over 5 years of preclinical/clinical development experience in an FDA regulated medical environment. (No food or beverage industry

5. Clinical research experience.

6. Solid understanding of biostatistics and clinical trial design.

7. Experience in guiding preclinical and clinical development efforts

8. Proficient in Microsoft Office suite.

9. Experience with Minitab. - NICE TO HAVE:

10. Science or Engineering Post-Graduate Degree. - NICE TO HAVE:

11. Clinical research experience working with CRO’s - NICE TO HAVE:

12. Experience Project Management and Microsoft Project. - NICE TO HAVE:

13. Salary Expectation?

14. US Citizen or Green Card holder.

15. Complete Current Address?

Additional pre-screen questions:

1. This role requires over 5 years of clinical/preclinical FDA medical regulated experience. Please elaborate on your experience:

2. What has been your exposure and experience in working with biostatistics and clinical trial design?

3. Please tell us how successful you've been in guiding preclinical and clinical development efforts. Please provide examples.

4. Are you within commuting distance of Cambridge, MA? If not, how open are you to relocating at your own expense?




Reference : Medical Device Senior Clinical Research Specialist - 1 jobs

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