Clinical Systems Lead: Validation & Compliance

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.

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

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.