Cristcot

Director, Clinical Operations – Sponsor Side

Cristcot

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Support the Sponsor-side research team in clinical research activities including Phase 2 and Phase 3 studies
  • Manage third-party vendors and internal study teams
  • Oversee adherence to the Company’s Quality Management System (QMS)
  • Track study schedules, deliverables, and execution monitoring
  • Document and organize studies in compliance with regulations and SOPs
  • Communicate with Senior Clinical Team about objectives, timelines, and deliverables
  • Organize study operations documents and facilitate QA/QC checks.
  • Support study start-up through closeout

Requirements

  • Bachelor’s degree or higher in a scientific or clinical related discipline
  • 8+ years of relevant life sciences industry experience, including but not limited to clinical trial operations management, and regulatory compliance experience strongly preferred
  • Experience working with and managing outside vendors/contractors
  • Working knowledge of industry standards including GCP, ICH, FDA regulatory compliance, etc.
  • Fast learner who is happy to take on any project
  • Strong attention to detail and follow-through
  • Excellent oral and written communication
  • Literature research skills with consistent practice of written documentation
  • Excellent computer skills including Microsoft Office (Word, Excel, PowerPoint, Veeva, CTMS, eTMF, EDC and IRT systems)
  • Diligent and focused
  • Strong budget monitoring and effective time management skills
  • Ability to work independently and communicate effectively in a team environment while showing leadership within the given discipline
  • Motivated by milestone achievements and accomplishments for personal/professional growth and the success of the business team as a whole
  • Willing to travel within the United States when needed up to 50%
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial operations managementregulatory complianceliterature researchbudget monitoringtime management
Soft Skills
attention to detailoral communicationwritten communicationindependent workteam communicationleadershipfast learnerdiligentfocusedmotivated