Quality Assurance Clinical Trial

Maria Eller

Escondido, CA 619-***-**** *****.*.*****@*****.***

Senior Clinical Trial Manager with 15+ years of experience overseeing global clinical trial operations across multiple therapeutic areas. Excellent at ensuring compliance with regulatory standards and study protocols. Successful in leading cross-functional teams, coordinating trial activities, and providing quality assurance based on SOPs. Skilled in vendor management, budget administration, and presentation of trial results to stakeholders. Worked in Phases I-IV drug development with 8 years of non-CRO research experience (in Academia, hospital research administration). Recognized by Kaiser Permanente Hospital with Excellence in Leadership Award for starting Oncology Research Program and opening 23 sites throughout Kaiser Hospital in Southern California. CORE COMPETENCIES

Clinical Operations Project Management Site Logistics Regulatory Compliance Quality Assurance Quality Control Trial Execution ICH & GCP Risk Management Continuous Improvement Documentation Process Development THERAPEUTIC AREAS

Oncology: Solid Tumors, Lymphoma Hematology: Anemia, Leukemia Immunology: Lupus Cell & Gene Therapy: Device Dermatology: Psoriasis, Actinic Keratosis, Dermatitis Infectious Diseases: HIV, Hepatitis C, COVID-19 Vaccine Trial PROFESSIONAL EXPERIENCE

Abbvie San Diego, CA April 2023 to August 2024

Senior Clinical Trial Manager / Senior Project Manager

● Played a key role in creating and editing clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and other clinical trial-related documents

● Prepared and reviewed site study documents (e.g., Monitoring Plan, Lab Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.) to support trial integrity

● Ensured compliance with ICH/GCP and applicable regulations, including management through resolution (e.g. CAPA) of any site or study level issues or deviations

● Ensured Trial Master File (TMF) was audit-ready for strong quality assurance and quality control

● Tracked and reported on current study progress including site activation, patient enrollment, monitoring visits, and data entry backlogs

● Monitored investigational product (IP) study drug accountability and reconciliation process

● Provided oversight for CRO’s and third-party vendors to ensure compliance with study protocols in accordance with scope of work; identified areas of concern and escalated to Clinical Operations Management Pfizer Remote September 2022 to April 2023

Senior Clinical Trial Manager

● Coordinated data review and cleaning which led to database lock and resolved site performance issues

● Directed vendor selection process and supervised performance of other CROs and third-party vendors to ensure achievement of contact objectives

● Administered site qualification and selection process with strict rubric of requirements for quality trial execution

● Identified risks, performed risk mitigation, and shared results with Senior Project Leadership and Operational Program Lead to reduce project delays

● Monitored study budget against study progress and timeline, properly allocating resources, approving vendor invoices, and reviewing investigator’s grant and pass-through cost (PTC)

● Ensured project management components are inspection ready including Trial Master Files

● Supervised an eight-member cross-functional study team and conducted weekly study team meetings to ensure achievement of performance goals

● Provided operational input into development and revision of study protocol and protocol-related documents ICON / PRA Remote October 2021 to September 2022

Senior Clinical Trial Manager

● Increased patient enrollment to 80% by opening three EU sites and driving effective advertisement/outreach efforts

● Completed study ahead of deadline through strategic time management, excellent project management, and proactive team communication

● Reviewed monitoring reports and ensured tracking of ongoing issues to mitigate risk

● Reviewed Essential Documents to ensure sponsor and investigator obligations were met and in compliance with applicable local regulatory requirements and ICH guidelines

● Organized and analyzed data as required for clinical operations performance and project status metrics

● Addressed and resolved clinical issues for client research projects including timely resolution of aging inquiries

● Recommended and implemented enhancements to clinical systems, including upgrading the CTMS for faster speed to increase efficiency and accuracy

● Identified out of scope tasks from clinical team and escalated to Project Manager for review, leading to 80% reduction in resources, thus decreasing cost

● Directed clinical operations team on a project by providing study specific and therapeutic training as well as mentoring for junior staff

● Participated in corporate initiatives, process improvements and PRA working groups to drive continual organizational success

May 2020 to October 2021: Completed continuing education courses maintain Registered Dietitian (RD) license Therapeutics, Inc. San Diego, CA June 2012 to April 2020 Senior Director, Clinical Operations

● Supervised daily clinical trial activities, including delegation of projects, staff training, budgeting, QA, logistics, and development of protocol documents

● Oversaw 24-member cross-functional Team (Regulatory, QA, DM/Stats) to ensure corporate and departmental goals were met within required timelines

● Evaluated budgetary requirements for clinical operations projects and conducted feasibility studies for fair market value assessments and presented results to internal stakeholders

● Identified risk and implemented risk mitigation strategies to resolve issues and maintain trial integrity

● Assisted in third-party vendor selection, training, and management to support trial compliance with industry regulations

● Ensured Study specific management tools, trackers and Trial Master File Maintenance Plan were set up before study and maintained throughout project/study life cycle

● Assisted in clinical data reviews of CRFs against redacted source documents and provided feedback to CRAs/Monitors

● Provided clinical support to Regulatory Affairs to prepare for audits by third party and/or regulatory authorities

● Identified staffing needs based on current and future projects, assisted in hiring qualified staff, and participate in weekly team meeting to provide study updates to senior management and study team

● Assisted in the selection of sites/investigators by reviewing site qualification visit reports to ensure adequate space and materials needed for proper clinical study

● Passed FDA inspection without findings (no 483) and PAS was approved by the FDA as a result of strong attention to detail and strict adherence to industry regulations Therapeutics, Inc. San Diego, CA

Senior Clinical Project Manager

● Coordinated and executed all operational and logistical activities for 8 dermatological drug and/or device clinical studies

● Facilitated protocols, ensured adherence to industry regulations, and developed documentation for SOPs

● Trained and mentored junior CRAs in Good Clinical Practices (GCP) and ICH standards to build a high performing and knowledgeable team

● Facilitated investigational site budget negotiations for up to $300K based on forecasted labor and required resources

● Oversaw final study report preparation to ensure accuracy and completeness before presentation to corporate executives

● Developed and presented effective oral and written presentations at internal and sponsor meetings for IMs, staff training, and organizational business planning

TECHNICAL SKILLS

Salesforce EDC CTMS CDM Systems: InForm EDC, Medrio, Rave EDC EDUCATION

Master of Science in Human Nutrition, University of New Haven New Haven, CT Bachelor of Science in Dietetics, University of Santo Tomas Philippines

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