Preclinical Study Monitor

Location
Lexington, Massachusetts (US)
Posted
Jul 02, 2018
Required Education
Bachelors Degree
Position Type
Full time

Scope:
Wave Life Sciences USA seeks an experienced and highly motivated individual to join its 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 from various external vendors. The individual will also act as the liaison between the Preclinical Development and Bioanalytical groups to ensure alignment of supporting studies.

Responsibilities:
Collaborate closely with Wave toxicologists and bioanalytical scientists, study teams (internal/external) and Contract Research Organization (CRO) partners

  • Provide Wave scientists with initial pricing for individual studies or programs for budgeting award the CRO for procedures to be outsourced
  • Travels to contract labs to monitor procedures on active studies as needed
  • Works 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 support to Bioanalytical group

  • Ensure samples analysis studies are in-line with supporting needs of toxicology studies
  • Attend relevant Bioanalytical scientists group meetings regularly
  • Communicate study timelines to Bioanalytical scientists and Clinical Operations Group
  • Communicate any assay issues to Bioanalytical scientists immediately

Communicate with Tox/PK study managers and CTMs before study start up to devise sample shipment and data/report delivery timelines

Establish and execute processes to qualify external partners and source non-GLP and GLP toxicology studies.

  • Performs initial, as well as follow-up CRO lab qualifications
  • Ensure adherence to project and overall departmental budgets by assessing areas for additional cost saving measures throughout the course of the study
  • Manages issue resolution discussions as necessary

Support implementation and management of nonclinical 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 and clinical trial 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 Director / Bioanalytical Scientist / Study Monitor in a preclinical toxicology group is essential
  • Demonstrated understanding of GLP and regulatory requirements for the conduct on toxicology studies
  • Experience qualifying / auditing CROs for selection of executing nonclinical 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)