Preclinical Study Coordinator

Location
02421, Lexington
Posted
Sep 04, 2018
Required Education
Bachelors Degree
Position Type
Full time
  • Wave Life Sciences USA seeks an experienced and highly motivated individual to join its Preclinical Development team in Lexington, Massachusetts. The selected individual will support multiple preclinical programs and be responsible for establishing and maintaining effective sourcing of preclinical and bioanalytical studies by proactive communications and study monitoring to ensure timely delivery of high quality study reports at various external vendors. The individual will also act as the liaison between the Wave departments and Contract Research Organizations (CRO) to confirm and track deliverables of collected samples, data and reports to ensure alignment of supporting studies is properly coordinated.  Oversight of Wave programs by active monitoring of preclinical studies will be the primary responsibility with potential growth opportunities to support Bioanalysis (BioA), Research and Clinical Operations.

Responsibilities:
May include some or all the following:

  • Collaborate closely with Wave toxicologists, study teams (internal/external) and CROs
    • Provide Wave scientists with initial pricing for individual studies or programs for budgeting and award studies to CROs
    • Travel to contract labs to monitor procedures on active studies as needed
    • Work closely with Wave scientists and CRO personnel to ensure study timelines remain on track
    • Be responsible for processing timely/accurate invoice payments and support budget forecasting
  • Provide project management support with current studies
    • Attend relevant toxicology / project management group meetings regularly
    • Work closely with project management colleagues in all Wave departments to ensure study timelines are aligned with overall project timelines
  • Track and communicate study timelines to various teams
  • Communicate with various internal groups to coordinate and track sample shipping
  • Work closely with internal groups and CRO Labs to coordinate and track report deliverables
  • Support implementation and management of preclinical toxicology projects through file management and document control
  • Assists the preclinical toxicology program in project related activities, such as maintaining vendor trackers, material shipping logistics, and drafting study related documents, as needed
  • Assists in the planning and preparation for study-related meetings with internal as well as external collaborators
  • Maintains study tracking tools and study calendars
  • Works closely with various functional groups, and CROs to ensure adequate nonclinical documentation
  • Stays current on CRO industry news and changes to business models

Education / Experience:

  • B.S. / M.S. or equivalent in biology, biochemistry, toxicology or a related field
  • 5 or more years of experience in a biopharmaceutical company
  • Experience as a study monitor and/project management tools in a preclinical setting is essential
  • Demonstrated understanding of GLP and regulatory requirements for the conduct of toxicology studies

Skills / Pre-requisites:

  • Excellent communication and interpersonal skills
  • Superior understanding of Microsoft Office products
  • Aptitude for organizational detail and ability to manage multiple projects
  • Capacity to complete tasks independently in a highly-regulated environment
  • Flexibility to function well within a team environment and within condensed timelines
  • Ability to verbalize complex study issues and demonstrated problem-solving ability
  • Documented knowledge of regulatory requirements and good laboratory practices (GLP)