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Clinical Study Manager
GENEWIZ
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Clinical Study Manager

GENEWIZ

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Details
Posted:
February 12, 2021
Location:
South Plainfield, New Jersey
Type:
Full Time - Experienced
Years of Experience:
2 - 4
Preferred Education:
4 Year Degree

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.

  • 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:

  • 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

NOTES:
Telecommuting is allowed.
About GENEWIZ
As a global leader in R&D genomics services, GENEWIZ leads the way in providing superior data quality with unparalleled technical support to enable researchers around the world to advance their scientific discoveries faster than ever before. Our customers at top-tier pharmaceutical, biotechnology, and academic institutions, as well as cutting-edge start-ups, rely on GENEWIZ's proprietary technologies for consistent, reliable, high-quality data, even on the most difficult projects. A full-service provider, GENEWIZ provides Sanger DNA sequencing, gene synthesis, molecular biology, high throughput/next generation sequencing, bioinformatics, and GLP regulatory services. GENEWIZ has a growing network of genomics laboratories around the world. Our customers are supported by state-of-the-art facilities and highly qualified scientific teams. GENEWIZ Regulatory Services, located in South Plainfield, NJ, are subject to rigorous quality systems based on Good Laboratory Practice (GLP), Clinical Laboratory Improvement Amendments (CLIA) regulations and College of American Pathologist (CAP) standards. GENEWIZ Suzhou, China and Takeley, UK locations also hold the ISO:9001 Quality Management ...Certification, a voluntary international certification noting operational excellence and quality standards. Headquartered in South Plainfield, NJ, GENEWIZ is owned by Brooks Automation with a global network of laboratories in Boston, MA; Washington, DC Metro; Research Triangle Park, NC; San Diego, CA; Los Angeles, CA; San Francisco, CA; and Seattle, WA. International locations include Beijing, Suzhou, Tanjin, and Guangzhou China; Takeley, United Kingdom; and Tokyo, Japan.
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