About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Job Summary:

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.

Primary Relationships:

• Within the company, the Director, Clinical Operations will collaborate closely with the Chief Executive Officer and Senior Clinical Team.
• Outside the company, the Director, Clinical Operations coordinates with vendors and service providers in the clinical trial areas of; clinical trial execution, clinical supply inventory, quality management and regulatory compliance.

Primary Job Responsibilities:

The primary goal of the Director, Clinical Operations is the management of operations that support the Company’s clinical studies under Good Clinical Practice and the maintenance of documentation under the Company’s Quality Management Systems (QMS).

The Activities of the Director, Clinical Operations (Sponsor Side):

• 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

Skills and Qualifications:

• 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%