Clinical Documentation Specialist

Clinical Documentation Specialist II – TMF / Clinical Research
Location: North Chicago, IL – Hybrid Preferred
Contract Duration: 12 Months
Schedule: Hybrid
Experience: 4+ Years Relevant Experience
Pay: $33-$37.50/hr based on benefit selections
 
Orion Group is seeking an experienced Clinical Documentation Specialist II to support clinical trial documentation and Trial Master File (TMF) activities for a leading pharmaceutical organization in North Chicago, IL.
This role is responsible for ensuring assigned Trial Master Files remain complete, accurate, timely, compliant, and inspection-ready throughout the clinical trial lifecycle. The Clinical Documentation Specialist will partner closely with study teams, document owners, and cross-functional stakeholders to monitor TMF health, perform quality assessments, resolve documentation issues, and proactively identify potential compliance risks.

The ideal candidate will have hands-on experience with clinical document management and TMF/eTMF processes, strong analytical skills, and the ability to independently manage documentation activities across multiple clinical studies.

Top Qualifications

• 4+ years of relevant industry experience in clinical document management, TMF/eTMF, or clinical research operations.
• Hands-on experience supporting Trial Master File completeness, quality, timeliness, and inspection readiness.
• Strong ability to engage document owners and cross-functional study teams to resolve documentation issues and drive accountability.
• Analytical and critical-thinking skills with experience reviewing TMF health metrics, identifying trends and risks, and implementing mitigation strategies.
• Excellent organizational and project management skills with the ability to manage documentation activities across multiple clinical studies simultaneously.

Key Responsibilities

TMF & Clinical Document Management

• Support the ongoing completeness, accuracy, quality, and timeliness of Trial Master File documentation.
• Ensure assigned Master Files remain inspection-ready and compliant with applicable clinical documentation requirements and ICH-GCP guidelines.
• Actively engage document owners to ensure study team members remain accountable for their respective sections of the Master File.
• Conduct quality checks throughout the document filing process and work with document owners to resolve identified quality issues.
• Support the finalization and archiving of study Master Files within the electronic TMF system.

TMF Health, Quality & Compliance

• Continuously monitor TMF health metrics and key quality indicators to identify emerging trends, gaps, and potential compliance risks.
• Develop and support mitigation strategies to address TMF completeness, timeliness, and quality concerns.
• Conduct Master File Oversight Quality Assessments and initiate appropriate follow-up actions with functional areas.
• Proactively escalate documentation risks and unresolved issues to ensure timely resolution.
• Perform QC checks on document processing completed by internal and external team members to ensure established quality thresholds are maintained.
• Support audit and regulatory inspection preparation to maintain ongoing TMF readiness.

Cross-Functional Collaboration

• Partner with document owners, study teams, and cross-functional stakeholders to resolve documentation issues and harmonize documentation practices.
• Facilitate discussions and meetings related to TMF quality, compliance, and remediation activities.
• Prepare and distribute periodic Master File oversight communications and reports.
• Create and present TMF status and health reports to study teams and key stakeholders.
• Drive accountability across functional areas for outstanding or deficient documentation.

Process Improvement & Training

• Contribute to internal business process teams, continuous improvement initiatives, and documentation-related workstreams.
• Provide recommendations for SOPs, work instructions, and job aids related to clinical documentation processes.
• Serve as a subject matter resource for clinical document management practices.
• Provide training and support to new team members and help reinforce document management best practices.
• Identify gaps within existing clinical documentation processes and recommend practical solutions.

Required Qualifications

• Bachelor's degree or international equivalent preferred, with a minimum of 4 years of relevant industry experience in clinical document management, TMF/eTMF, or equivalent clinical research experience.
• Candidates without a bachelor's degree may be considered with a minimum of 6 years of relevant professional clinical research experience.
• Strong knowledge of clinical documentation processes and procedures.
• Understanding of Trial Master File management and ICH-GCP requirements.
• Proven analytical and critical-thinking abilities.
• Ability to identify documentation gaps, assess risks, and recommend appropriate solutions.
• Strong written and verbal communication skills.
• Ability to facilitate cross-functional discussions and work effectively with stakeholders across multiple functions.
• Excellent organizational skills with the ability to manage multiple clinical studies and competing priorities simultaneously.
• Ability to work autonomously with limited oversight.
• Proficiency with Microsoft Excel and PowerPoint.

Ideal Candidate
The ideal candidate is an experienced TMF/eTMF or clinical documentation professional who understands that inspection readiness requires more than simply filing documents. This individual will be comfortable analyzing TMF health, identifying gaps and trends, holding stakeholders accountable for documentation requirements, and driving issues through resolution.
They should be highly organized, analytical, proactive, and confident in communicating with cross-functional clinical study teams while independently managing documentation activities across multiple studies.
 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.