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Medical Device Senior Full-time Job

3 weeks ago Computing and ICT Cambridge   87 views
Job Details

Medical Device Senior Clinical Research Specialist

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.

Company Description
The Karen Hospital is a 102 bed multispecialty Hospital in Kenya located in Karen along Karen –Langata Road, Nairobi. We offer patient focused, world class medical treatment and accord the highest standards of medical care to all our patients indiscriminately.
With our State of the art amenities, equipment and our well trained staff, we are committed to delivering the most effective and most compassionate care to all our patients.