Director, Clinical Operations (Sponsor Side)

Cristcot

9d

About The Position

Cristcot is seeking a Director, Clinical Operations to support the Sponsor-side research team in the continued clinical research activities of the company, including the startup of a Phase 2 clinical study, a Phase 3 study in development, and other ongoing clinical study projects. The role will entail the management of third-party vendors, internal study teams including data, regulatory oversight and study execution monitoring. The Director, Clinical Operations will work with the Senior Clinical Team to oversee adherence to the Company’s Quality Management System (QMS) through audit ready file organization including regulatory activities. The Director, Clinical Operations will track ongoing study schedules, deliverables, and document ongoing study execution monitoring and protocol adherence.

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%

Responsibilities

• Documentation and filing associated with our QMS; documenting internal activities; documenting external outsourced services, and communicating the expectations of study design, deliverables, and timelines to our vendors and internal teams
• Organization and planning of study operations documents (contracts, insurance, logistics, etc.)
• Monitor and organize study deliverables and facilitating the necessary QA/QC checks
• Communicate with Senior Clinical Team regarding internal team and vendor objectives, timelines, and deliverables
• Documentation of Sponsor monitoring and oversight in accordance with the Code of Federal Regulations and Company SOPs
• Organization and support of study start up through closeout

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1-10 employees