BuffaloRecruiter Since 2001
the smart solution for Buffalo jobs

Nonclinical Studies Manager

Company: Cameron Craig Group
Location: Buffalo
Posted on: July 12, 2019

Job Description:

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 experts.
  • 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 experience
    • M.S. (or equivalent degree) and 3+ years relevant work experience
    • B.S. (or equivalent degree) and 6+ years of relevant work experience
    • Excellent written and oral communication, interpersonal and problem-solving skills
    • Strong understanding of how to manage nonclinical studies, organize nonclinical data, and write research reports.
    • Understanding of the drug development process and global regulatory guidance
    • Proficient in Microsoft-- Suite (Word, Excel, PowerPoint, Project). Experience with electronic document management and tracking systems is a plus.
    • Preferred:

      o------Experience in oncology, toxicology, and/or pharmacokinetics
      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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Assistant Reservations Manager
Description: Our Exciting Work Environment Our call center is located in the Northpointe Commerce Park in Amherst, NY. The Assistant Manager must be able to work third shift in support of our Australian operations, (more...)
Company: Delaware North
Location: Buffalo
Posted on: 07/17/2019

Senior Manager, Retail Sales
Description: JOB SUMMARY br The Sr. Manager of Spectrum Retail Sales is responsible for building, owning and driving a sales culture across Authorized Retailers within the assigned market. The Sr. Manager of Spectrum (more...)
Company: Spectrum
Location: Rochester
Posted on: 07/17/2019

Director, Master Data Management
Description: The Opportunity At Delaware North we have a a long history of operational success and we have ambitious goals for our future growth and operating performance. These aspirations are supported by a transformative (more...)
Company: Delaware North
Location: Buffalo
Posted on: 07/16/2019

Master Data Management Leader
Description: Take Your Career Beyond the Ordinary To the Extraordinary At Delaware North, you'll love where you work, who you work with, and how your day unfolds Top five reasons to bring your unique talents to Delaware (more...)
Company: Delaware North
Location: Buffalo
Posted on: 07/16/2019

Assistant Branch Manager
Description: DescriptionResponsibilities br As an Assistant Branch Manager ABM , you'll be responsible for the daily operations, and opening and closing of the branch. This includes management of sales and service (more...)
Company: Citizens Bank
Location: Rochester
Posted on: 07/17/2019

Business Analytics Analyst II/ Project Manager- Legal Division
Description: Job Details Company Overview Overview: Responsible for providing operational, financial, analytical, and technical support to the Legal Division, and more specifically, to the Legal Operations group. (more...)
Company: M&T Bank
Location: Buffalo
Posted on: 07/17/2019

Sales Team Manager
Description: Interwork Technologies is an award-winning North American distributor of security software solutions that is a great place to start or accelerate your career in cybersecurity.--Desired candidates are (more...)
Company: Interwork Technologies
Location: Buffalo
Posted on: 07/16/2019

Adult Health Home Care Manager
Description: Order : NY Catholic Family Center is seeking a full time Adult Health Home Care Manager in our Restart Outpatient program. General Description Under general supervision, recruits new referrals (more...)
Company: Catholic Family Center
Location: Rochester
Posted on: 07/17/2019

Physician: Pain Management Physician Need in Pennsylvania wi
Description: A new pain management physician opportunity is now available in Pennsylvania at an established solo practice. They also welcome anesthesiology and PM R physicians. They are looking for someone to come (more...)
Company: CompHealth
Location: Erie
Posted on: 07/17/2019

Assistant Director of Nursing - Room for Professional Growth & Excelle
Description: Assistant Director of Nursing - Room for Professional Growth Excellent Pay Full-Time - Monday thru Friday Looking to take the next step in your career as a nurse and step into a director role Ready (more...)
Company: MedSense Recruiting
Location: Rochester
Posted on: 07/16/2019

Log In or Create An Account

Get the latest New York jobs by following @recnetNY on Twitter!

Buffalo RSS job feeds