Study Operations Lead

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

If you are interested in the below position, please send your resume [e-mail] and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.

Role

Responsible for the end-to-end execution of clinical studies (from final protocol to data delivery of final study reports), facilitating cross-functional study team collaboration, ensuring appropriate trial oversight, identifying and managing risks and regular communication of study updates.

Key Responsibilities

• Primary Clinical Operations point of contact for a specific study or set of studies
• Provides oversight and project management activities throughout the project lifecycle of the trial, including timelines and deliverables from all functional areas and vendors
• Develops and maintains study documents, trackers, and key study information
• Works with the cross-functional project team to identify and evaluate issues and risks in the program and suggests and implements solutions.
• Communicates study information to team members and TG leadership
• Leads or contributes to process improvement initiatives, audits and inspections

Professional Experience/Qualifications

• Experience in Clinical Trials
• Experience and ability to provide the organization with the skills required to lead a clinical trial team
• Thorough knowledge of clinical research process
• Knowledge of FDA and global regulations and their practical implementation
• Strong verbal and written communication skills
• Ability to manage and prioritize workload effectively. Excellent time management, project coordination, and organizational skills

Education

• University degree in life sciences or related fields

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.