Senior Study Operations Lead — Clinical Trials

TG Therapeutics, Inc.; Raleigh (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

A biotechnology company in Raleigh seeks a Clinical Operations Lead to oversee the execution of clinical studies. Key responsibilities include managing project timelines, ensuring compliance with FDA regulations, and serving as the primary contact for trials. Candidates should have a university degree in life sciences, experience in clinical trials, and strong communication skills. This role offers an opportunity to contribute to innovative treatments for B-cell diseases in a dynamic environment.

Responsibilities

• Serve as primary Clinical Operations contact for specific studies.
• Manage oversight and project activities throughout the trial lifecycle.
• Maintain and develop study documents and trackers.
• Identify and evaluate issues in the program to implement solutions.
• Communicate study details with team members and leadership.
• Lead process improvement initiatives, audits, and inspections.

Skills

Clinical Trials

Team leadership

Clinical research process

Regulatory knowledge (FDA and global)

Communication skills

Time management

Project coordination

Organizational skills

Education

University degree in life sciences or related fields

Job description

A biotechnology company in Raleigh seeks a Clinical Operations Lead to oversee the execution of clinical studies. Key responsibilities include managing project timelines, ensuring compliance with FDA regulations, and serving as the primary contact for trials. Candidates should have a university degree in life sciences, experience in clinical trials, and strong communication skills. This role offers an opportunity to contribute to innovative treatments for B-cell diseases in a dynamic environment.