Clinical documentation Specialist

The Clinical Documentation Specialist is responsible for managing and maintaining Trial Master File (TMF) documentation throughout the clinical trial lifecycle to ensure completeness, accuracy, timeliness, and inspection readiness. The role collaborates with document owners, study teams, and cross-functional stakeholders to resolve documentation issues, perform quality checks, monitor TMF health metrics, and ensure compliance with ICH-GCP and applicable clinical documentation requirements. The specialist also supports audits and inspections, prepares TMF oversight reports, contributes to SOP and process improvements, and provides guidance and training to study teams and document management staff.

• 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.
• 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.