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Clinical Operations Lead III

Austin, TX 73301

Posted: 01/12/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 538646 Pay Rate: 76.42 Is job remote?: Yes Country: United States

Job Description

The Clinical Operations Lead will support the implementation and execution of the company's clinical trials by performing specific tasks at country, regional and site level. This person will ensure trial conduct is efficient, with seamless execution, achievement of timelines and study results with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures.

Major Responsibilities:
  • Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity in support of one or more projects.
  • Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required
  • Develop Protocol Monitoring Plan (PMP)
  • Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements and status of CSM activities
  • Prepare, coordinate, deliver, and track protocol specific training
  • Initiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies from sites for assigned trial(s)
  • Create and maintain user account worksheets for provisioning all site personnel for assigned trials into required systems (e.g. EDC, IRT, training portals)
  • Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation

Competency Profile
  • Customer Focus
  • Action Oriented
  • Collaborates
  • Communicates Effectively
  • Plans & Aligns

Preferred Qualifications:
  • Bachelor's degree in life science; Medical, pharmaceutical, biology, chemistry degree preferred.
  • The ability to fluently read, write, understand and communicate in English
  • Clinical trial management experience, field clinical monitoring, or site management (e.g., study coordinator) experience
  • 5 Years of Relevant Experience Education
  • Travel requirements: 5-10%

Pay rate between $30-65/hr
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