Clinical Study Manager

Location: South Plainfield, New Jersey, United States of America

Do you have an entrepreneurial spirit? Do you have a passion for clinical research? Are you driven and results oriented with a desire to learn new skills? If so, we encourage you to consider a Clinical Study Manager within our Preclinical and Clinical Services Department. In this role, you will have the opportunity to get firsthand insights into our client’s clinical programs service as the primary point of contact between the sponsor, CRO, and our genomics specialty laboratory services. This position offers a great learning opportunity by working within a dynamic space with cutting edge technology and direct access to Subject Matter Experts.

Title:                      Clinical Study Manager

Location:              South Plainfield, NJ

Responsibilities:

  • Coordinate and lead client communications during the project scoping stage.
  • Engage Subject Matter Experts and Department Head on technical and business matters.
  • Lead internal communications with operations leads to ensure smooth knowledge transfer
  • Work within the team to develop and implement project plans
  • Draft study plans, final reports and other documents as required
  • Manage and monitor active client projects from sample receipt through delivery
  • Provide regular updates to clients on project status and relay key information between client and operations.
  • Review current protocols and business practices. Make process improvement recommendations and implement

Qualifications:

  • Bachelor’s Degree, Master’s Degree, or Doctorate Degree in the biological sciences required
  • 3+ years of experience in clinical research and/or laboratory experience in molecular diagnostics
  • Experience monitoring or coordinating pharmaceutical research or pharmaceutical services projects
  • Knowledge of data quality control and bioanalytical study record keeping
  • Working knowledge of GLP/GCLP (required) and CLIA/CAP (preferred)
  • Detail oriented, able to multitask and work in a deadline-driven, customer-oriented team environment
  • Proficiency in MS Office365 including Word, Excel, PowerPoint, Teams, and Project
  • Strong organizational skills and attention to detail
  • Ability to communicate effectively both orally and in writing
  • Client-first attitude

EOE M/F/Disabled/Vet