Caroline G.

ABOUT ME I support clinical teams, sponsors, and independent consultants in developing high-quality clinical trial documentation that reflects the level of their work. Grounded in 20 years of clinical operations experience across study start-up, site activation, and TMF oversight, I interpret complex protocols, regulatory requirements, and operational workflows into clear, structured, and compliant materials that support both execution and communication across the trial lifecycle. I’m new to Upwork, but not new to this work. I bring 20 years of clinical operations experience, along with contract writing experience in general marketing and content development. CORE SERVICES I work across both documentation development and operational support, depending on what a team needs at a given stage. If you need relible, knowledgeable expert for any of the below, I'd love to hear more and learn how I can help you. Clinical Documentation & Writing Services - Informed Consent Forms (ICFs): drafting, editing, and readability optimization - Patient-facing materials (guides, newsletters, study communications) - Clinical trial plans (Project Management, Safety, Start-Up, Monitoring, Risk Management, Quality) - Site-facing communications and updates Operational & Regulatory Documentation Services - SOP development (study start-up, TMF, regulatory processes) - Work instructions and process documentation - TMF plans, structure, and quality documentation Systems & Training Materials Services - CTMS user manuals and system documentation - Training materials for study teams and operational workflows - Process guides to support consistent system adoption CLIN OPS CONSULTING I provide: - Support for early-stage or evolving clinical operations functions - Study start-up process development and documentation structuring - Collaboration with sponsor-side teams and independent consultants to deliver high-quality materials ABOUT MY EXPERTISE My experience spans the full study lifecycle, with a focus on study start-up, documentation, and operational execution. I know: - Phase I–III clinical trials (global, multi-site) - Study start-up and site activation - Regulatory submissions and essential document management - TMF/eTMF governance (including Veeva Vault) - Audit and inspection readiness aligned with ICH-GCP WHAT I'VE WORKED ON: I’ve supported clinical programs across a broad range of therapeutic areas, including: Oncology | Neurology | Endocrinology | Gastroenterology | Women’s Health | Ophthalmology | Infectious Disease | Rare Disease | Biologics | Medical Devices | IVD MY EXPERIENCE: With 20 years of experience across CRO, biotech, and medical device environments, I am well-prepared to work at the much-needed intersection of clinical operations, documentation, and communication translating complex trial processes into materials that support both execution and understanding. Here's what I've done over the years: - Clinical operations leadership across biotech, CRO, and IVD environments - Directed study start-up and site activation across multi-country trials - Developed, drafted, and reviewed clinical documentation including Study Plans, ICFs, SOPs, and study materials - Authored and led systems UAT, including test scripts and front- and back-end user manuals - Launched and managed clinical operations departments and processes - Interpreted protocol and operational requirements into structured, compliant documentation - Managed TMF quality and document governance - Led cross-functional coordination across clinical and regulatory teams - Developed documentation for site- and client-facing communications WHAT I WRITE: Examples of the types of materials I regularly develop and support: - Informed consent forms supporting clarity and compliance - SOPs and operational documentation - CTMS user manuals and system documentation - Newsletters and study communications - Documentation quality control supporting audit and inspection readiness TECH KNOWLEDGE I’ve worked across a range of clinical systems and platforms, such as: - eTMF / CTMS: Veeva Vault, Trial Interactive, SimpleTrials, Anju ClinPlus, proprietary CTMS platforms - Other Systems: IRT/EDC, Salesforce, Oracle - Learning Management Systems: SABA, Learnflex - Tools: Microsoft Office Suite, Canva, Adobe Suite, Power BI, Tableau - AI Tools: Claude, Gemini, Perplexity, ChatGPT - Methodologies: Agile Regulatory & Compliance My work is grounded in established regulatory frameworks and extensive knowledge of global standards.I know: ICH-GCP | 21 CFR Part 11 | E6(R3) GCP | FDA | OHRP | EudraCT | EMA | Health Canada | MHRA | PMDA | NMPA | CDSCO | DCGI | TMF Reference Model (DIA HOW I WORK I bring a practical, operations-based perspective to documentation. Having worked across clinical teams and study lifecycles, I focus on materials that are not only compliant, but also usable—supporting teams, sites, and patients in real-world settings.