Clinical Documentation Specialist

Client Industry: Pharmaceutical / Medical Device / Biotechnology

Location: North Chicago, IL 60064 – Hybrid

Duration: 12-month contract with possibility of extension based on performance and business needs

Pay

$30.00 – $36.00 per hour

Responsibilities

• Actively engage with document owners 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 and harmonize documentation practices.
• Resolve quality issues during the document filing process.
• Prepare and deliver detailed reports and presentation materials to stakeholders; contribute to and potentially lead internal Business Process Teams and continuous-improvement initiatives.
• Provide input and recommendations for Standard Operating Procedures (SOPs), work instructions, and job aids; serve as a subject-matter expert and mentor new hires.
• Prepare and distribute periodic Master File Oversight emails and reports; conduct Master File Oversight Quality Assessments and initiate functional-area reviews.
• Proactively escalate and resolve issues related to Master File completeness, timeliness, and quality.
• Maintain consistent reporting format and frequency.
• Create and present reports to study teams; collaborate with functional areas to finalize and archive study Master Files in the electronic system and support audit/inspection preparations.
• Continuously monitor TMF Health metrics to detect trends, identify risks, and implement mitigation strategies to ensure document integrity and compliance.
• Conduct QC checks on document processing by internal and external staff to ensure quality thresholds are met.

Requirements

• Bachelor’s degree or international equivalent preferred; minimum 4 years of relevant industry experience in clinical document management or equivalent.
• If no bachelor’s degree, a post-degree plus a total of 6 years of professional clinical-research work experience is required.
• Proven analytical and critical-thinking skills.
• Proficient knowledge of clinical-documentation business procedures.
• Ability to work autonomously with limited oversight.
• Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
• Compliance with clinical-documentation processes, ability to 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 simultaneously.
• Experience using MS PowerPoint and Excel.

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan
• Life insurance and long-term disability insurance
• Short-term disability insurance
• Paid parking or public-transportation subsidy
• Paid time off, sick and safe time, vacation time, and parental leave (eligibility requirements apply)
• Paid holidays annually