Mgr/Sr. Manager, Clinical Systems

TG Therapeutics, Inc.; Raleigh (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

A biopharmaceutical company located in Raleigh, North Carolina is seeking a Manager/Senior Manager, Clinical Systems to lead projects related to clinical systems implementation and validation. The ideal candidate will have over 5 years of clinical systems experience in the pharmaceutical or biotech sectors. Responsibilities include working with cross-functional teams to ensure compliance and effective system usage, alongside technical management of GxP systems.

Qualifications

• 5+ years of clinical systems or IT experience, at least 3+ years in the pharmaceutical, biotechnology, or CRO industry.
• Proven track record leading clinical systems across the full lifecycle.
• Strong understanding of clinical trial processes, ICH/GCP guidelines, and regulatory requirements.

Responsibilities

• Partner with Clinical Operations to translate system requirements into technical specifications.
• Serve as liaison between functional groups and IT for issue resolutions.
• Track business metrics to measure system effectiveness and utilization.
• Develop and maintain technical documentation, system architecture maps, and support workflows.
• Ensure secure, reliable data exchange between internal systems and external partners.
• Coordinate system enhancements and ensure regulatory compliance across projects.

Skills

Project management

Stakeholder management

Problem-solving

Attention to detail

Vendor management

Education

Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or related field

Tools

MS Project

Smartsheet

Jira

Job description

Title: Manager/Senior Manager, Clinical Systems

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, 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 Manager/Senior Manager, Clinical Systems reports directly to the VP, Clinical Operations. This position requires strong pharmaceutical industry experience to lead and support the planning, execution, and delivery of systems projects — with a primary focus on clinical systems but also including other function’s initiatives as needed.

The Manager/Senior Manager, Clinical Systems will partner with cross-functional stakeholders—including Clinical Operations, Data Management, Pharmacovigilance, Quality, and IT—to effectively implement, validate, maintain, and retire systems in accordance with compliance requirements and business needs. The technical ownership of the GxP systems will enable each business/functional areas to focus on their efforts to collect and analyze patient/drug/safety data in compliance with global health authority regulations.

The ideal candidate will have hands‑on experience managing clinical trial technology platforms (such as EDC, CTMS, eTMF, IRT, safety systems, and reporting tools), with demonstrated expertise in system validation, implementation, lifecycle management, and change management.

Key Responsibilities

Primary Responsibilities

• Partner with Clinical Operations, Data Management, and Pharmacovigilance to understand system requirements and translate them into technical system specifications to ensure clinical systems (EDC, CTMS, eTMF, IRT/RTSM, Safety database) meet end‑user needs.
• Serve as liaison between functional groups and IT for enhancements, issue resolutions and upgrades
• Track business metrics and KPIs to measure system effectiveness and utilization.
• Ensure secure, reliable, and compliant data exchange between internal systems and external partners.
• Develop and maintain technical documentation, system architecture maps, and support workflows.
• Prioritize activities and solutions in alignment with overall corporate/business strategies. Review, analyze and evaluate business systems and user needs. Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations. Ensures documentation of process and system, functional and business requirements, and objectives for technology initiatives.
• IT Technical SME for system activities for system/process enhancements and integration projects. Coordinates support activities across vendor(s) for support and maintenance and ensures the proper delivery of services.

Technical Responsibilities

• System Validation
  • Oversee computer system validation (CSV) activities in line with GAMP 5, 21 CFR Part 11, and ICH/GCP guidelines.
  • Author and execute test scripts to validate system changes and enhancement
• System Implementation
  • Manage change control process, including the authorship and review of system change controls to ensure compliance with GxP and regulatory requirements
  • Ensure clinical systems follow internal SOPs, quality management practices, and regulatory guidelines.
  • Develop and lead cross‑functional review of relevant system SOPs
  • Maintain audit‑ready documentation for all clinical system activities
  • Ensure systems are prepared for regulatory inspections and internal audits.

Expanded Responsibilities

In addition to core responsibilities, the Manager/Senior Manager, Clinical Systems may also take on expanded responsibilities depending on organizational needs and workload. These may include:

System Business Owner–Aligned (Clinical Focus)

• Perform user access reviews and periodic system access recertifications.
• Coordinate periodic system reviews for compliance, functionality, and performance.
• Draft and maintain SOPs, work instructions, and governance documents.
• Partner with QA to oversee training compliance for system users.

Broader Cross‑Functional IT Focus

• Support IT leadership with portfolio management, resource planning, and risk reporting.
• Provide PMO‑style governance and best practices across IT.
• Support cross‑departmental system integrations (ERP, HRIS, financial systems).

Professional Experience/Qualifications

• 5+ years of clinical systems or IT experience, with at least 3+ years in the pharmaceutical, biotechnology, or CRO industry.
• Proven track record leading clinical systems across the full lifecycle — from selection and implementation through validation, maintenance, change management, and retirement.
• Strong understanding of clinical trial processes, ICH/GCP guidelines, and regulatory requirements.
• Deep experience with system validation (CSV), lifecycle management, and change management.
• Familiarity with 21 CFR Part 11, GxP, and GDPR requirements.
• PMP or equivalent certification strongly preferred.

Skills

• Excellent organizational, communication, and stakeholder management skills.
• Strong problem‑solving ability and attention to detail.
• Ability to balance multiple priorities and pivot between clinical and non‑clinical projects.
• Proficiency with project management tools (MS Project, Smartsheet, Jira, etc.) and collaboration platforms.
• Strong vendor and CRO management experience.
• Ability to work effectively in a fast‑paced, matrixed environment.

Education

• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or related field; advanced degree preferred.

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.