Director, Clinical Operations – Sponsor Side
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Job Description
Director of Clinical Operations managing Sponsor-side clinical research activities for Cristcot. Overseeing studies, vendor management, and adherence to quality management standards.
Responsibilities:
- 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
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