Clinical documentation Specialist

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

Purpose

• The Clinical Document Management Associate II will ensure the Master File is always inspection-ready and complies with ICH GCP guidelines.
• This role entails the conduct of rigorous quality checks, ensuring reliable and complete Trial Master File. Collaborate with study teams, providing support to address and resolve issues related to Master File health indicators.
• Focus on maintaining the completeness, accuracy, and timeliness of all crucial documents throughout the lifecycle of the assigned clinical trials.

Responsibilities:

• Actively engages with document owners to ensure that study team members are accountable for their respective sections of the Master file.
• Work collaboratively with document owners and cross-functional teams to resolve document-related issues and harmonize documentation practices.
• Actively engages with document owners to resolve quality issues during the document filing process.
• Prepares and delivers detailed reports and presentation materials to stakeholders, as well as contributes to and potentially leads internal Business Process Teams and initiatives focused on continuous improvement projects and work streams.
• Offers valuable input and recommendations for Standard Operating Procedures (SOPs), work instructions, and job aids, serving as a subject matter expert and potentially mentoring new hires.
• Prepares and distribute periodic Master File Oversight emails and reports, conduct Master File Oversight Quality Assessments, and initiate actions for functional area reviews.
• Proactively escalates and resolves issues related to Master File completeness, timeliness, and quality, ensuring that any challenges are addressed promptly and efficiently. Maintain a consistent reporting format and frequency.
• Creates and presents reports to study teams, collaborating with functional areas to finalize and archive study Master Files in the electronic Master File system, and supporting audit and inspection preparations to ensure Master File readiness.
• Continuously monitor TMF Health metrics to detect emerging trends, identify potential risks, and implement effective mitigation strategies to ensure document integrity and compliance.
• Offers expert input and recommendations for Standard Operating Procedures (SOPs), work instructions, and job aids, serving as a subject matter expert.
• Provide training and support to new team members, serving as a mentor to guide best practices in document management and conducts QC Checks on document processing of internal and external staff to ensure quality thresholds are being met.

Requirements:

• Ability to actively engage with document owner to ensure study team members are accountable for their respective sections of the Master file.
• Work collaboratively with document owners and cross-functional teams to resolve document-related issues.
• Analytical and critical thinking skills.
• Continuously monitor TMF Health metrics to detect any trends, identify potential risks and implement mitigation strategies to ensure document integrity and compliance.
• Excellent organizational skills with ability to manage several studies at the same time.

Qualifications:

• Bachelor's degree or international equivalent preferred. Minimum 4 years relevant industry experience in clinical document management or equivalent experience required.
• If no bachelor's degree, a total of 6 years professional clinical research relevant work experience.
• Proven analytical and critical thinking skills.
• Proficient knowledge of clinical documentation business procedures.
• Capable of working autonomously with limited oversight.
• Proven oral and written communication skills; ability to facilitate cross-functional team meetings.
• Compliant to clinical documentation processes, identify gaps and propose solutions.
• Collaborative mindset to work effectively across various teams and departments.
• Excellent organizational skills with the ability to manage several projects at the same time.
• Experienced in using Microsoft PowerPoint and Excel.