2018-05-02

Clinical Development Senior Manager
Job Opportunity at Clinical Dynamix, Inc.

Posted on May 2

http://www.clinicaldynamix.com    888-558-2546

Location: Madison, NJ
Job Type: Full Time
Job ID: W4158737

The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development.
 
 
supports the Clinical Program Lead  and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy.  key Clinical Development contact for the Clinical Trial Team and is responsible for:
  • Representing Clinical Development as a core team member on the Clinical Trial Team
  • Providing a clinical review of study-specific documentation and training materials
  • Performing clinical data reviews
  • Design eCRF, data capture, listings, review patient profiles to identify and resolve issues.
  • Assessing reported protocol deviations
  • Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team
  • Prepare for investigator meetings
  
 
Preferred Skills/Qualification
  • Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
  • Understands and leverages cross-functional roles and responsibilities
  • Ability to understand implications of strategic decisions
  • Identifies and implements best practices
  • Demonstrates basic understanding of global pharmaceutical/ device product development
Education
 
Bachelor’s degree required, Advanced science degree (e.g., MS, MD, PharmD, PhD); Scientific knowledge and experience in multiple Therapeutic Areas preferred.  (CNS, Pain, and Migraine a plus).
 
 

PLEASE ANSWER the following question

1. What is your experience with Data Review (designing E crf, or Jreview, clinical data, as examples)- and then they will ask what does that mean to you? So be ready to provide details
2. What is your expereince with Study Start up
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