Danielle Dunnivant

• Provided expert guidance on eTMF system (Veeva Vault) to implement strategies for quality enhancement and productivity optimization.
• Supported eTMF vendors in validating and configuring Veeva Vault system to ensure seamless implementation and operational efficiency.
• Directed user account configuration and ongoing support within eTMF system to optimize operational efficiency and user experience.
• Facilitated eTMF system site license requests to maintain compliance with system agreements.
• Managed and streamlined study TMF processes, ensuring adherence to compliance standards and improving efficiency in clinical study operations.
• Evaluated and validated system access needs to ensure operational efficiency.
• Leads creation and maintenance of the TMF Plan and TMF Index and other applicable TMF plan attachments.
• Created and implemented eTMF training initiatives, consistently integrating updates on system improvements and newly added features.
• Ensured accurate recording of deviations from established TMF business processes and operating models to maintain compliance.
• Addressed and escalated compliance issues to ensure adherence to regulatory standards.
• Coordinated and executed the receipt and processing of eTMF report requests tailored to sponsor and study team requirements, enhancing operational efficiency.
• Assisted in preparing the TMF for QA or sponsor audits and inspections. Supported audit and inspection processes as needed.
• Managed artifact processing to support study integrity and adherence to established SOPs, GCP, and ICH standards.
• Analyzed study data and program metrics to identify emerging trends for management review.
• Evaluated and resolved TMF content quality concerns to maintain high standards of documentation.
• Coordinated eTMF system release and feature updates, ensuring adherence to requirements and providing comprehensive training for personnel on system enhancements.
• Conducted comprehensive comparisons of two eTMF systems, outlining key configurations and features to facilitate implementation of an improved eTMF solution.

• Executed updates and maintenance of the Electronic Trial Master File (eTMF) system to support study site information and user account management.
• Developed and implemented study-specific TMF Index to enhance project efficiency. Oversaw ongoing maintenance of TMF plans to ensure compliance and organization.
• Served as TMF Subject Matter Expert, offering in-depth knowledge and strategic insights.
• Piloted training initiatives for newly assigned personnel on eTMF system. Delivered comprehensive support to study teams to enhance system utilization.
• Facilitated setup of electronic eTMF for designated study teams.
• Ensured adherence to proper file naming standards to facilitate streamlined document management.
• Managed the systematic upload of critical documents into eTMF, enhancing data organization and retrieval efficiency.
• Conducted documentation status updates for assigned studies, ensuring timely and accurate record-keeping.
• Reviewed eTMF content regularly to maintain compliance and accuracy. Assisted in tracking and obtaining outstanding or missing documentation.
• Conducted thorough quality assessments of eTMF documentation to verify proper scanning, naming, and integration of physical documents into the eTMF system.
• Performed regular assessments and quality control of the electronic trial master file to maintain compliance standards for inspections.
• Analyzed internal audit findings and partnered with the study team to effectively resolve identified discrepancies.

• Collected, maintained, and tracked all study-level essential documents in the eTMF, ensuring compliance with ICH GCP guidelines.
• Facilitated communication with the project team to ensure alignment with project requirements and timely task completion.
• Reviewed adverse event and protocol deviation logs, ensuring accurate trending and summarization by site and category.
• Completed data line listing reviews and executed data cleaning activities prior to data locks.
• Expediently reported any adverse events to the sponsor and coordinated with sites for accurate documentation.
• Facilitated timely submission of investigator payments to ensure compliance with financial requirements.
• Maintained continuous verbal and written communication with site monitors, project managers, and related study staff.

• Collaborated with operations to configure trial interactive enterprise software and solutions.
• Engineered and documented innovative configurations and solutions for trial interactive software.
• Created and maintained User Requirements Specification and Configuration Specifications for implementing customers as part of the onboarding process.
• Functioned as the product configuration and domain expert in all relevant sales cycles with specific responsibility for demonstrating the product to prospects and existing customers.
• Collaborated with sales on requirements gathering and software configurations for demonstrations and responded to functional and technical questions.
• Served as a conduit between the Sales team and Operations and Product teams, clearly conveying customer/prospects and business requirements from the field to the Operations and Product teams.
• Developed and scripted product and solution demonstrations.
• Disseminated the Trial Interactive vision through product demonstrations, webinars/seminars, conferences, and account-specific initiatives.
• Aided in the drafting and review of Standard Operating Procedures (SOP).

• Delivered comprehensive support for document management and clinical operations systems to enhance team efficiency.
• Initiated comprehensive trial setup in CTMS and eTMF systems to ensure compliance and operational efficiency.
• Coordinated clinical systems implementations to enhance document management processes and ensure compliance.
• Orchestrated eTMF knowledge transfer by training new users and study team members on system functionalities and best practices.
• Provided document management support for clinical teams during study startup and peak document flow periods.
• Managed tracking and preparation of departmental information using databases, spreadsheets, and various tools.
• Conducted TMF SOP reviews and ensured effective management of TMF QC processes across all trials.
• Oversaw management and tracking of study-specific contracts and clinical study payments within relevant systems.
• Managed and tracked clinical and non-clinical supplies, including purchasing and shipping processes.
• Facilitated development and distribution of site binders to enhance project organization.
• Coordinated meetings to facilitate team collaboration. Assisted in documenting and distributing meeting minutes to ensure clear communication. Supported team members in following up on action items.

• Attended Trusted Process meetings such as Kick-Off, Quick Start Camps, Jump Start Camps, Quality Finish Camps, etc., as TMF Subject Matter Expert (SME).
• Facilitated effective communication and presentation of TMF status updates to stakeholders.
• Led TMF set up and established a structured approach for completeness reporting. Oversaw the creation of tailored completeness reports for sponsors and projects. Developed comprehensive lists of required documents and executed gap analysis to identify deficiencies.
• Actively involved in Project Point, including Gateway set-up and training for the Project Team, as applicable.
• Collaborated with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted and published promptly and with high quality to maintain the TMF in an audit-ready state.
• Formulated strategic plans to enhance compliance and monitored non-compliance issues, as necessary.
• Contributed expertise in TMF during internal project team and sponsor meetings to enhance project outcomes.
• Developed and delivered study-specific TMF training through teleconferences, video conferences, and in-person sessions.
• Compiled and delivered completeness reports and inspection readiness metrics to the project team.
• Participated in audits/inspections and prepared for audits to ensure audit-readiness for the TMF.
• Facilitated regular feedback and training sessions for the project team on TMF health and status.
• Analyzed and established TMF best practices to enhance operational efficiency and effectiveness.
• Facilitated quality finish meetings as TMF representative, providing strategic guidance to project and regulatory records teams during final QC and completeness reviews.

• Initiated authoring of Investigational Product Information Manual (IPIM) and study-specific Important Protocol Deviation (IPD) list.
• Prepared Clinical Study Team (CST) meeting agendas and minutes.
• Submitted documents to Trial Master File (TMF) in Veeva Vault.
• Provided support for the Study Start-Up Team.
• Responsible for the coordination and management of study vendors.
• Created and managed study-specific tools.
• Managed process for planning and procuring equipment and ancillary clinical supplies.
• Maintained study-level history document.
• Compiled IRB/IEC submission documentation.
• Contributed to the preparation of training materials (Investigator Meetings/Site Initiation Training).
• Managed global versioning and distribution of informed consent forms (ICFs).
• Coordinated study required vendor access to applicable systems.
• Managed quarterly eTMF quality review for global study.
• Compiled study-level reports for distribution to study team members.
• Facilitated and managed Study Management Associate (SMA) requests.
• Maintained study team member listing in eClinical.

• Spearheaded development of investigational product information manual (IPIM) and study-specific important protocol deviation (IPD) list.
• Developed and documented meeting agendas and minutes to enhance team collaboration and communication.
• Uploaded and organized documents within the Trial Master File (TMF) in Veeva Vault.
• Coordinated resources and assistance to enhance the efficiency of study start-up processes.
• Oversaw coordination and management of study vendors to ensure project alignment.
• Developed and oversaw study-specific tools to enhance research efficiency.
• Oversaw planning and procurement processes for equipment and ancillary clinical supplies.
• Ensured accuracy and completeness of study-level history records to support research integrity.
• Organized and compiled IRB/IEC submission documentation to ensure compliance with regulatory standards.
• Collaborated in the preparation of comprehensive training materials to enhance investigator meetings and site initiation training effectiveness.
• Directed management of informed consent forms (ICFs) to ensure compliance and accessibility across global operations.
• Managed vendor access to necessary systems to ensure effective study execution.
• Conducted comprehensive quality reviews of eTMF on a quarterly basis to ensure compliance with global study standards.
• Compiled and disseminated study-level reports to enhance team collaboration and communication.
• Managed SMA requests, ensuring timely responses and effective communication with stakeholders.
• Maintained comprehensive listings of study team members in eClinical to support project coordination.

• Reviewed and verified veterans' insurance coverage details, ensuring compliance with pre-certification protocols.
• Conducted thorough validation of claims to support billing processes, referring any questionable coding for expert review.

• Managed comprehensive disaster recovery efforts to ensure resilience across 21 counties and state agencies in Tennessee.
• Engaged with all responsible applicants through regular contact and site visits to assess and meet recovery needs effectively.
• Supported disaster applicants in navigating recovery efforts, ensuring accurate completion of federal and state inspection payment forms.
• Facilitated completion of recovery processes for 50 applicants to ensure timely support following 4 separate disasters.
• Managed the processing of 48 grant contract amendments for four separate disasters, ensuring timely and accurate documentation.

• Directed comprehensive medical readiness training initiatives to enhance operational efficiency for 324 hospital members.
• Managed patient administration flight plans and programs to ensure efficient service delivery for 2.6k medical beneficiaries and 23k clinic visits annually.
• Implemented and maintained HIPAA program, resulting in a 99% compliance rate recognized during command consultative visit.
• Acknowledged for exemplary management of the medical evaluation board program, facilitating its adoption across two command bases to maintain consistent on-time case submissions over a 10-month period.
• Implemented targeted training initiatives for 109 geographically dispersed personnel, resulting in a 75% decrease in patient movement errors.