D
Dawn Pepper
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Pennsylvania, United States
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Full-time jobs
Résumé
Jobs
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- RSenior Clinical Trial ManagerReAlta Life SciencesJul 2026 - Current (4 months)• Serve as primary clinical operations lead for HIE program, ensuring delivery aligned with timelines, budget, quality standards, and regulatory requirements (GCP, SOPs).
• Lead end-to-end clinical trial execution, including site selection, patient recruitment, monitoring oversight, data collection, and study closeout activities.
• Develop and implement key operational plans (Clinical Management Plan, Monitoring Plan, Recruitment Strategy, and Training Plans) to drive efficiency and compliance.
• Identify study risks proactively and implement mitigation strategies to maintain timelines, enrollment targets, and data quality.
• Prepare study status reports, enrollment updates, and executive-level presentations.
• Pres 
Clinical LeadPremier ResearchJul 2025 - Jun 2026 (1 year)Provide end-to-end clinical leadership for global studies, ensuring achievement of operational milestones within contractual timelines, quality standards, and budget parameters.
• Lead site selection, initiation, and activation strategies to accelerate enrollment
• Oversee and mentor clinical monitoring teams, ensuring consistent delivery of high-quality monitoring outputs
• Develop and maintain study-specific Clinical Monitoring Plans and adaptive risk-based strategies
• Monitor clinical metrics, enrollment trends, protocol deviations, and data quality indicators
• Serve as primary escalation point for clinical risks, compliance issues, and sponsor concerns
• Partner with Project Management on timelines, forec- Senior Clinical Research AssociatePremier ResearchApr 2023 - Jul 2025 (2 years 4 months)Led site monitoring activities for Phase I–III trials with a focus on subject safety, data integrity, and regulatory compliance.
• Conducted remote and on-site monitoring visits (SIV, IMV, COV) per CMP
• Ensured completeness, accuracy, and timeliness of site data and documentation
• Managed query resolution and collaborated with Data Management to improve data quality
• Maintained TMF/eTMF in compliance with ICH-GCP requirements
• Proactively identified and escalated site-level risks and compliance issues
• Supported feasibility assessments, enrollment monitoring, and investigator meetings
• Acted as mentor and resource for junior CRAs - Clinical Research Associate II / IPremier ResearchOct 2021 - Mar 2023 (1 year 6 months)• Executed monitoring activities across multiple study phases with increasing complexity
• Maintained high standards for regulatory documentation, IP accountability, and site compliance
• Supported cross-functional teams to meet quality, timeline, and budget goals - HClinical Research CoordinatorHighmark Health Singer Research InstituteAug 2021 - Oct 2021 (3 months)• Coordinated day-to-day conduct of clinical trials at the site level
• Screened and consented subjects; conducted study visits and follow-up per protocol
• Maintained regulatory binders, CRFs, and source documentation
• Ensured protocol compliance and patient safety - PClinical Quality AnalystPhilips RespironicsSep 2019 - Aug 2021 (2 years)• Managed medical device complaint handling and post-market surveillance activities
• Authored and submitted MDRs and Manufacturer Incident Reports (FDA & EU MDR)
• Conducted complaint investigations and coordinated with cross-functional teams
• Supported regulatory inquiries, audits, and internal quality initiatives
• Provided training to internal and contract staff - ULead Registered Respiratory TherapistUniversity of Pittsburgh Medical CenterOct 2013 - Sep 2019 (6 years)• Led respiratory care for cardiothoracic surgery and transplant patients
• Supported clinical research initiatives related to ventilation and respiratory therapies
• Provided staff education, clinical mentorship, and served as acting clinical manager
Education
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- Bachelor of Science, Health ScienceSouthern New Hampshire University