Clinical Data Manager

Tg Therapeutics • Raleigh, NC

238d

About The Position

TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical 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.

Requirements

• Strong proficiency in Microsoft Office applications.
• Excellent attention to detail and organizational skills, with a commitment to producing accurate and high-quality work.
• Effective verbal and written communication skills, with an ability to convey complex information clearly and concisely.
• Familiarity with clinical data terminology and healthcare concepts.
• Ability to collaborate in a team-oriented environment and adapt to evolving priorities.
• Prior experience in clinical data management is required.
• A proactive and eager-to-learn attitude with a willingness to take on new challenges and responsibilities.
• Min 5 years of experience in Data Management.

Nice To Haves

• Preferred experience in Biotech/Pharma.

Responsibilities

• Independently specify, configure, and maintain highly complex clinical study databases and related tools including screen design, edit check development, query management, data extraction, and data management related reporting.
• Lead the planning and execution of User Acceptance Testing (UAT) for assigned EDC study databases. Perform all documentation activities as specified by company and department procedures.
• Assemble requirements from study teams to develop highly complex entry forms in EDC systems. Maintain EDC forms during study lifecycle.
• Utilize expert knowledge of industry data management processes and procedures to effectively lead highly complex data management projects and assignments.
• Create specifications and work closely with Clinical Data Programming to build highly complex Electronic Data Capture (EDC) study databases including edit checks and dynamic entry screens.
• Provide appropriate support and coordinate with other functional areas regarding overall clinical study conduct and management including protocol development, study start-up, study closeout, and data analysis.
• Maintain knowledge and understanding of current team, department, and corporate goals and priorities to ensure effective time management and focus.
• Assist in developing department and functional team goals.
• Exhibit consistent compliance with established department and company processes, procedures, guidelines, and best practices.
• Ability to work closely and effectively in a team-oriented environment with colleagues.
• Ability to deliver quality results in a timely manner, either independently or by directing others.

What This Job Offers

• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree