Overview

Job Title: Senior Clinical Trials Manager
Job Location: Palo Alto, CA, United States
Job Duration: Full Time Opportunity
Type of Hire: Direct Placement
Mode of Interview: Telephone Interview Followed by Video Interview.
Responsibilities:

  • Manage external vendors and contract research organizations
  • Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
  • Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
  • Assist with protocol development and study report completion
  • Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (Google Cloud Platforms), SOPs and study protocols
  • Provide guidance, direction, and management to CRAs
  • Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
  • Coordinate study supplies
  • Negotiate contracts with vendors of clinical trial services
  • Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings
  • Assist and support data query process
  • Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
  • Ensures trial master file is current and maintained

Required Knowledge, Skills, and Abilities:

  • At least 5 years of experience in clinical trial management Experience in CNS is preferred
  • Proven Management of people in a matrixed environment Management of global clinical trials
  • Demonstrated working knowledge of Google Cloud Platform, ICH guidelines and FDA regulations Demonstrated ability to work independently and in a team environment
  • Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
  • Excellent oral and written communication skills and strong organizational abilities

Required/Preferred Education and Licenses: BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
Description of Physical Demands:

  • Occasional mobility within office environment. Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment:

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

What are the 3-4 non-negotiable requirements of this position?

  • BA/BS, nursing degree, or advanced degree.
  • Degree in the life sciences preferred.
  • At least 5 years of experience in clinical trial management.
  • Manage external vendors and contract research organizations.
  • Must have experience sponsor, study management experience; CRO experience is not a fit.
  • Must have experience managing large global clinical trials *Proven Management of people in a matrix environment Management of global clinical trials

What are the nice-to-have skills?

  • Neuroscience experience is a plus

– provided by DiceTracking

To Apply: https://www.jobg8.com/Traffic.aspx?U2r8GOUiDKVcIGULUqGSxQm