Danielle Lester
Schertz,TX
Summary
Dynamic clinical research professional skilled in leading multiple clinical programs, ensuring regulatory compliance, and driving stakeholder engagement. Demonstrated ability to develop integrated project plans and performance metrics that enable successful execution and timely deliverables. Strong communicator adept at fostering collaboration across cross-functional teams.
Overview
6
6
years of professional experience
Work History
Program Manager
Hearing Center of Excellence
12.2023 - 02.2026
- Managed a portfolio of 6 clinical and research programs encompassing approximately 10 projects per program, coordinating planning, execution, progress tracking, deliverables, and stakeholder communications.
- Led program-level reporting and prepared executive-ready briefings for senior leadership, government clients, investigators, and other stakeholders.
- Developed and maintained project plans, milestones, performance metrics, and status reports to monitor progress and enable successful project execution.
- Coordinated activities across researchers, clinical subject matter experts, program leadership, and external stakeholders to ensure project deliverables met operational and regulatory requirements.
- Identified operational, regulatory, and project risks; implemented mitigation strategies to prevent delays and interruptions to project activities.
- Maintained visibility across multiple projects, ensuring priorities, action items, and stakeholder expectations were effectively managed.
- Facilitated clinical and scientific project communications, including manuscripts, conference abstracts, presentations, stakeholder materials, and leadership updates.
Research Administrator
Hearing Center of Excellence
03.2021 - 11.2023
- Coordinated clinical trial activities throughout study start-up, conduct, and close-out, working with clinical trial managers, research sites, CROs, monitors, vendors, investigators, and internal stakeholders.
- Developed and maintained integrated study plans, timelines, milestones, trackers, and status reports across multiple concurrent clinical research protocols.
- Collected, reviewed, tracked, and maintained site regulatory and essential documents, ensuring timely investigational product release and compliance with TMF/eTMF filing standards.
- Organized and supported TMF audits and study closeout activities, maintaining inspection readiness and compliance with applicable SOPs and regulatory requirements.
- Reviewed regulatory documents received from sites and CROs for completeness, accuracy, and compliance with applicable procedures and guidelines.
- Coordinated CRO and third-party vendor activities, facilitating onboarding, tracking deliverables, and following up on issues to support seamless study execution.
- Performed first-pass review of site and vendor invoices and maintained financial trackers and monthly/quarterly accrual information for finance.
- Tracked CDAs, CTAs, MSAs, work orders, and other study agreements, ensuring adherence to legal and approval processes to support research integrity.
- Supported development and maintenance of study tools and documentation, including site training materials, regulatory templates, study binders, study plans/manuals, communications, and presentations.
- Utilized EDC and CTMS systems to analyze and report enrollment, randomization, data-cleaning, safety/SAE, and other trial metrics for project and management reporting.
- Ensured ongoing regulatory compliance, audit preparedness, documentation quality, and adherence to federal research standards.
Clinical Research Coordinator
Diabetes Center of Excellence
Lackland AFB, USA
01.2020 - 02.2021
- Coordinated patient recruitment, enrollment, follow-up, and study-related activities, enhancing participant engagement in diabetes research and education programs.
- Collaborated with investigators and research stakeholders to support project objectives, data collection, and regulatory requirements.
- Developed departmental SOPs to standardize research processes and establish guidance for future research personnel.
- Facilitated diabetes education sessions, increasing community awareness and understanding among participants at local centers.
- Developed research poster for 2021 San Antonio Universities Research Forum (SURF), showcasing findings to academic and professional audiences.
Education
Bachelor of Science - Business Management
Western Governors University
05-2022
Associate of Science - Administrative Assistant
Career Point College
01-2016
Medical Assistant Program -
Career Point Institute
01-2004
Skills
- Site Management & Study Support
- Document control
- Document management
- GCP/ICH Compliance
- Visit preparation
- Informed Consent Process Support
- Monitoring Visit Preparation & Follow-Up
- Clinical Trial Management
- Clinical procedures
- Enrollment tracking
- Cross-Functional Communication
- Clinical Data Management
- Microsoft Office (Advanced)
Publications
- Estimated Incidence and Prevalence of Asymmetric and Unilateral Sensorineural Hearing Loss in United States Military Service Members, Hecht, D. Q., et al., 2026, Military Medicine
- An Examination of Eustachian Tube Dysfunction in an Adult TRICARE Population, Esquivel, C., 2024, Defense Technical Report
- Diabetes Self-Management Education and Support (DSMES), Diabetes Center of Excellence, 2021, San Antonio Universities Research Forum (SURF), San Antonio, TX
Therapeutic Experience
- Cardiovascular
- Hypertension
- Hypercholesterolemia
- Diabetes
- PTSD
- Traumatic Brain Injury
- Multiple Sclerosis
- Alzheimer's Disease
- Hearing Loss
- Tinnitus
- Vestibular Disorders
- Pain Management
- Migraine
- Asthma
- Dermatology
- Osteoporosis
- Renal Impairment
- Gastrointestinal Disorders
- Infectious Disease/Vaccines
Timeline
Program Manager
Hearing Center of Excellence
12.2023 - 02.2026
Research Administrator
Hearing Center of Excellence
03.2021 - 11.2023
Clinical Research Coordinator
Diabetes Center of Excellence
01.2020 - 02.2021
Bachelor of Science - Business Management
Western Governors University
Associate of Science - Administrative Assistant
Career Point College
Medical Assistant Program -
Career Point Institute