Clinical Trial Manager Associate - Brisbane, United States - Vera Therapeutics

Mark Lane

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Mark Lane

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Description

Title:
Clinical Trial Manager Associate


Location:
Brisbane, CA**
About Us:Our values are the cornerstone of our culture.

Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.


Position Summary:


The Clinical Trial Manager Associate will report to the Senior Director, Clinical Operations and will be responsible for providing support to the clinical operations study teams for assigned responsibilities of a study/studies.


Responsibilities:


  • Manages assigned parts (vendor and/or global region) of studies of large scope and high complexity
  • Assists with the development of department initiatives, process documents and standard forms
  • Assist in review of study documents (ICFs, plans, forms, trip reports, etc.)
  • Interacts with the study team and other departments with within the company to complete assigned tasks
  • As needed, arranges meeting logistics, agendas and assist with minutes
  • As needed, tracks, analyzes, and prepares studyspecific information utilizing databases, spreadsheets, and other study tools
  • Serve as a back up to the Clinical Trial Manager and team
  • May lead a component of a routine clinical study such as TMF review
  • May conduct, with oversight, site evaluation, initiation, monitor or comonitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
  • Mentors and supports more junior team members (CPA)
  • Travels as required. 1020% domestic

Qualifications:


  • Bachelor's Degree or equivalent experience
  • 2 years of clinical trial experience within clinical operations at a biotech or pharmaceutical company
  • Collaborative demeanor
  • Exceptional organizational skill and communication skills, both spoken and written with the ability to plan, organize, and prioritize multiple work assignments and goals
  • Strong ability to work with crossfunctional team members and external vendor
  • Working knowledge and experience with Word, PowerPoint, and Excel
Vera Therapeutics Inc. is an equal opportunity employer.


COVID-19 Policy
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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.


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