Clinical Data Manager Position Available In Wake, North Carolina

Clinical Data Manager

Location:

Raleigh, NC
If you are interested in the below position, please send your resume to careers@tgtxinc.com and

REFERENCE THE POSITION TITLE

within the subject line.
Organizational Overview
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.
Role
The Clinical Data Manager is responsible for ensuring the accurate, complete, and timely collection, management, and delivery of clinical data for analysis, reporting, and presentation. The Clinical Data Manager acts as Lead Data Manager on highly complex clinical studies and projects either independently or by directing others, providing expert Clinical Data Management functional representation to study teams.
As a Data Manager, you will play a pivotal role in the data lifecycle, from collection and organization to reporting and analysis, ensuring that data is optimized for use across various systems and stakeholders.
Key Responsibilities
Key Responsibilites include, but are not limited to, the following:

• -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.
  Professional Experience/Qualifications
• -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
• -Preferred experience in Biotech/Pharma
  Education
• -Bachelor’s degree in a relevant field (e.

g., Biology, Health Sciences, Public Health, Statistics, or related discipline) or equivalent experience.
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.