Clinical Trial Manager

San Diego, CA

Contract

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Overview

At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization committed to correcting the imbalance of gene expression and associated cellular pathways to treat a broad range human disease. The role as Clinical Trial Manager is located in San Diego, California.  This position is for a self-driven professional looking to get things done.

Responsibilities

  • Manage in-house CRAs, CROs and vendors.
  • Set-up performance objectives and timelines for projects within the scope of the company goals.
  • Train and supervise CRA’s and CRO staff on applicable SOPs.
  • Ensure clinical team compliance with GCPs and ICH guidelines by setting up reports to monitor CRA daily activity and provide additional training required on applicable regulations, ICH guidelines and GCPs.
  • Provide mentorship to clinical team.
  • Assign tasks and functions for the CRAs and other clinical operations staff regarding their roles on the study teams.
  • Lead regular study team meetings and provide updates to Director of Clinical Operations.
  • Identify prospectively any issues that will interfere with meeting project goals and recommend solutions.
  • Ensure clinical trial documents are filed, maintained, and archived in audit-ready and due diligence-ready condition.
  • Identify site auditing frequency for compliance with applicable regulations and the monitoring requirements set up for a particular study, oversee efficiency and appropriateness of CRA travel, data monitoring and field performance.

Experience

  • Minimum of seven years of clinical operations experience in the biotechnology or pharmaceutical industry.
  • Demonstrated understanding of all applicable regulations and guidelines governing drug. development including ability to apply these to overall strategic drug development.
  • Highly organized, Strong analytical skills, highly attentive to details, and strong work ethic.
  • Ability to work within schedules and deadline.
  • Team player, intensely committed to success and getting the job done well in a highly dynamic environment.
  • Ability to multitask, prioritize, and function in a fast-paced entrepreneurial environment.
  • Self-motivated, ability to work independently while also willing to follow protocols.
  • Demonstrated ability to generate reproducible results, and to teach others.
  • Ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Willing to travel for training and supervisory purposes or to assist with complex, difficult clinical sites.
  • Invest time to expedite and complete assignments or projects, as required.

Qualifications

  • Bachelor’s degree in a life science/Master’s preferred or its equivalent in health care or biological science.

 

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