Clinical Documentation Standards

• Ensure documentation aligns with ISO 14155 for medical device clinical investigations and applicable ICH-GCP guidelines.
• Support in ethical approval processes by ensuring all applicable templates and documentation meet ethical standards and comply with any ethical committee requirements.
• Develop and maintain standardized clinical document templates (protocols, monitoring plans, ICFs, etc.) that are applicable for use across multiple study applications.
• Develop and maintain work instructions, SOPs and procedures for use across the clinical department.
• Complete annual gap analysis of the existing documentation at both a sponsor and site level, where gaps are identified create clear processes, timelines and supporting WIs/templates for implementation.
• Review and update existing clinical SOPs, WIs, and procedural documentation annually in alignment with:
  • ICH-GCP E6 (R3)
  • ISO 14155:2020 (Clinical Investigation of Medical Devices)
  • FDA 21 CFR Part 812, Part 11
  • EU MDR documentation standards

Document Control & Quality Oversight

• Ensure controlled documents are appropriately authored, reviewed, approved, and archived per company document management SOPs.
• Maintain traceability logs, version control logs, change histories, and audit trails for all documentation.
• Act as document control delegate for all clinical documentation, ensuring timely release for use and accurate version tracking.
• Assist in preparation for audits, inspections, and internal quality reviews.

Cross-Functional Collaboration & Support

• Act as a subject matter expert (SME) on clinical documentation practices for internal teams.
• Support training and onboarding of new clinical staff regarding document standards and CRF completion guidelines.
• Work closely with Medical Writers to identify and create any documentation required to execute clinical investigation plans on an individual study basis.
• Provide study specific training sessions to CTAs and other site level staff to outline all documentation required, provide overview of any new study specific templates and data collection timepoints.
• Work closely with CRA and CTA Manager to resolve documentation discrepancies and ensure compliance and consistency at investigational sites.

Experience/ Skills:

Essential

• 3+ years of experience in clinical research, with direct involvement in CRF design, WI/SOP writing and clinical documentation control.
• Experience working on medical device trials, especially pre-market (feasibility, pivotal) studies.
• Ability to interpret regulatory guidance into SOPs/WIs.
• Strong technical writing, proofreading, and document formatting skills.
• Meticulous attention to detail.
• Detail-oriented with excellent organizational and version control capabilities.
• Proficient in document management systems (eTMF systems) and Microsoft Office Suite.
• Familiarity with EDC platforms.
• Knowledge of clinical operations processes.
• Cross-functional communication skills.

Desirable

• Experience supporting aesthetic, dermatologic, or medical device studies at both sponsor and site level.
• Understanding of data collection best practices, coding systems (MedDRA,) and risk-based monitoring.
• Ability to work independently while managing multiple projects in a fast-paced environment.
• Collaborative mindset with a commitment to cross-functional excellence and process improvement.

Education/ Qualifications/ Training:

Essential

• Bachelor's degree in Life Sciences, Health Sciences, Biomedical Engineering, or a related field.
• Proven deep knowledge of clinical documentation and applying regulatory frameworks (FDA, ISO, GCP, MDR)
• Deep knowledge of GCP (ICH E6 R3), ISO 14155 (device trials), 21 CFR Part 11 (electronic records), 21 CFR Part 812 (device IDE studies) and the ability to translate this regulations to practical documents.
• FDA & EMA guidance on clinical documentation
• Familiarity of good documentation practices (GDP)