Nonclinical Studies Manager
Company: Cameron Craig Group
Posted on: July 12, 2019
Buffalo, NY, United States----Full Time
As a Nonclinical Studies Manager in Preclinical Sciences you will
work closely with internal Preclinical, Toxicology, Regulatory, and
Clinical staff as a subject matter expert in nonclinical study
design, and you will with work with external CROs to provide
oversight in the review and/or QC of study proposals, protocols,
data, and reports, in support of Client development programs. You
will participate in project team meetings and help to manage and
drive nonclinical timelines for regulatory submissions. You will
serve a technical writing role, composing nonclinical summaries
and/or reports for pharmacology, pharmacokinetic pharmacology
studies conducted by or on behalf of Client, and be an expert user
of the nonclinical document templates that are consistent with FDA
and ICH guidelines and with electronic submissions guidelines.
Key responsibilities include the following:
- Assist Scientific Managers and Toxicologists with CRO
management activities, including communicating with study
directors, obtaining and reviewing study proposals, composing and
reviewing protocols/reports, and meeting study timelines.
- Perform routine oversight of CROs to ensure study adherence
with regulatory requirements/GLP compliance.
- Compose and manage review/QC cycles for nonclinical summaries
and documents in collaboration with subject matter
- Lead discussions regarding nonclinical study requirements,
documents, and timelines in context with the overall program
development of a drug.
- Performs other duties as assigned.
Required Education and Qualifications
- Ph.D. (or equivalent degree) and 0-3 years relevant work
- M.S. (or equivalent degree) and 3+ years relevant work
- B.S. (or equivalent degree) and 6+ years of relevant work
- Excellent written and oral communication, interpersonal and
- Strong understanding of how to manage nonclinical studies,
organize nonclinical data, and write research reports.
- Understanding of the drug development process and global
- Proficient in Microsoft-- Suite (Word, Excel, PowerPoint,
Project). Experience with electronic document management and
tracking systems is a plus.
o------Experience in oncology, toxicology, and/or
o------Experience in scientific writing
o------Resourcefulness, pragmatism, and independent work ethic
o------Can manage multiple projects under tight timelines, working
independently and collaboratively
Keywords: Cameron Craig Group, Buffalo , Nonclinical Studies Manager, Executive , Buffalo, New York
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