TMF Master File Quality Lead - Clinical Docs

Katalyst CRO; North Chicago (IL); On-site; USD 70,000 - 100,000; Full time

Job summary

Katalyst CRO seeks a Clinical Document Management Associate II to ensure the Master File stays inspection-ready and compliant with ICH GCP. You will perform rigorous quality checks and work with study teams to address TMF health indicators, across the document lifecycle.

Key duties include engaging with document owners, resolving issues with cross-functional teams, preparing reports, and aiding SOP development. Mentoring new hires and driving continuous improvement are also part of the role.

Qualifications

• Bachelor's degree or international equivalent required.
• Minimum 4 years of clinical document management experience.
• Strong analytical and critical thinking skills.
• Proficient knowledge of clinical documentation procedures.
• Autonomy with limited oversight.
• Excellent oral and written communication; cross-functional meetings.
• Proficient in PowerPoint and Excel.
• Collaborative mindset for cross-team work.
• Ability to manage multiple projects concurrently.

Responsibilities

• Engage with document owners to ensure TMF sections are accountable.
• Collaborate with cross-functional teams to resolve document issues and harmonize practices.
• Resolve quality issues during document filing.
• Prepare and present reports to stakeholders and contribute to process improvement initiatives.
• Provide input for SOPs, work instructions, and job aids as a SME; mentor new hires.
• Distribute periodic Master File Oversight emails and conduct quality assessments.
• Escalate and resolve TMF completeness, timeliness, and quality issues.
• Create and present reports to study teams; support audit and inspection preparations.
• Monitor TMF health metrics to detect trends and risks; implement mitigations.
• Provide training to new team members on document management best practices.

Skills

Analytical thinking

Critical thinking

Organizational skills

Communication skills

Cross-functional collaboration

PowerPoint

Excel

Autonomy

Education

Bachelor's degree

4+ years clinical document management

Tools

PowerPoint

Excel

Job description

Katalyst CRO seeks a Clinical Document Management Associate II to ensure the Master File stays inspection-ready and compliant with ICH GCP. You will perform rigorous quality checks and work with study teams to address TMF health indicators, across the document lifecycle.

Key duties include engaging with document owners, resolving issues with cross-functional teams, preparing reports, and aiding SOP development. Mentoring new hires and driving continuous improvement are also part of the role.