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January 20th, 2016

Clinical Studies Manager – Austin, TX

Clinical Studies Manager plays a major role in coordinating clinical studies, from qualification of clinical study sites through monitoring of clinical study activities and completion of clinical trials.

Required Education/Training:

  • Minimum MS/PhD in Molecular Biology, Biochemistry or related discipline with at least 3 years’ related experience in clinical trials OR
  • Minimum BA/BS degree in Molecular Biology, Biochemistry or related discipline with at least 6 years’ related experience in clinical trials

Required Work Experience:

  • Training & work experience in document and record management for clinical study (GCP)
  • Must have good understanding of 21 CFR Part 812 regulations and CLSI guidelines
  • Experience in a GMP and/or FDA regulated environment
  • Experience working independently in a fast-paced environment with rapidly changing priorities, as well as working well in a team-oriented environment
  • Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Can exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Strong organizational skills and exceptional time management and prioritization skills
  • Excellent verbal and written communication skills
  • Must work onsite
  • Travel may be required, including approximately 10% International travel

Clinical Studies Manager Key Responsibilities

This position is responsible for managing clinical study activities. The position plays a major role in coordinating clinical studies, from qualification of clinical study sites through monitoring of clinical study activities and completion of clinical trials. The position helps to ensure that clinical studies are executed in compliance to applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH). The position also involves writing of study protocols, reports, SOPs and other documents.

  • Manage the planning and execution of clinical studies
  • Play a leading role in the qualification of clinical trial sites
  • Coordinate collection and tracking of clinical study specimens
  • Participate in clinical site training, monitoring, and support
  • Play a role in the analysis and interpretation of clinical trial data
  • Establish scientific methods for design and implementation of study protocols and data collection systems that meet quality and regulatory requirements
  • Prepare clinical study final reports
  • Monitor adherence to protocols during clinical studies and determine study completion
  • Participate in project core teams by presenting clinical study status updates and data
  • Manage clinical trial resources and timelines in coordination with project core teams
  • Interact with various internal/external groups to facilitate completion of studies for inclusion in regulatory submissions for in vitro diagnostic devices
  • Conform to applicable regulations and standards and company quality policies

 

Contact:

Jan Clements

MEIRxRS

Jclements@meirxrs.com

 

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