Clinical Operations Consultant in Boston, MA at Apex Life Sciences

Date Posted: 5/21/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Boston, MA
  • Job Type:
    Consultant
  • Experience:
    Not Specified
  • Date Posted:
    5/21/2018
  • Job ID:
    799293

Job Description


Our client, a national consulting firm specializing in the clinical arena, is seeking a Clinical Operations and Development Specialist to join their expanding team.

As a team leader, you will manage multiple early to mid-stage clinical trials and programs for emerging biotech and pharma sponsor companies. These responsibilities may include the full scope of clinical project management or individual components based on the contracted scope of responsibilities.  You will be responsible for the execution of study-related tasks independently, including development of study tools, management plans, reports, timelines, and other critical study deliverables. You may also support cross functional program level activities as the clinical lead to create comprehensive clinical development plans. 

You can:

  • Independently manage one or more clinical drug trials, including CROs, Vendors, and cross functional team members; study start up through clinical study report
  • Perform occasional study qualification visits, initiation visits, routine monitoring visits and study close out visits
  • Work on a variety of client engagements with an aim to increase efficiency and success in clinical development
  • Outline clinical strategies and considerations to support clinical development plans, including modeling of program level timelines, budgets, study plans and competitive landscapes

Requirements 

  • B.S. and 6-10 years of experience in a biotech or pharma setting.
  • You will need broad experience in clinical operations (including clinical project management, CRO/Vendor selection and management, and monitoring) and the ability to support several projects for different client engagements simultaneously.
  • The ideal candidate will also have experience supporting program level strategic planning activities spanning from pre-IND through marketing approval. 
  • You’ll be expected to be highly proficient in the MS Word, Excel, Project, and PowerPoint.

Skills

  • Broad clinical experience across a variety of therapeutic areas, oncology experience highly desirable 
  • Excellent oral and written communication and presentation skills
  • Deep understanding of Good Clinical Practice
  • Process expertise to develop protocols, report forms, informed consents, operational documents to support our work
  • Action oriented, ready for responsibility, open to learning new skills and willing to help where and when needed
  • Demonstrated ability to work independently with exceptional organization and attention to detail 

Please email: mmiller@apexlifesciences.com for consideration.

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