Donova Lewis

About Donova Lewis

I am a dedicated Clinical Research Project Manager with a proven track record of transforming complex trials into successful outcomes. With extensive experience in both CRO and sponsor environments, I ensure projects stay on budget and on schedule, delivering high-quality results.My expertise includes developing and implementing robust research strategies, protocols, and methodologies that align with organizational objectives. I am proactive in identifying areas for improvement and excel in executing corrective actions, driving continuous improvement initiatives across projects.As a leader, I thrive in steering cross-functional teams and optimizing workflows, even in fast-paced and dynamic environments. I am also recognized for my strong communication and presentation skills, consistently building and maintaining positive relationships with clients and stakeholders.Therapeutic Expertise: • Ophthalmology • Cardiovascular (Pharma and Device) • Infectious Disease • Behavioral/Psychiatric • Dermatology • Respiratory • Endocrine • Urology • Gastroenterology (Pharma and Device) • Pediatric Vaccine • Women’s Studies (Pharma and Device) • Orthopedics (Pharma and Device) • Pain Management • Autoimmune Diseases • Oncology • Organ Transplant (Pharma and Device) • Rare Diseases • COVID-19 TreatmentTechnical Proficiencies: • Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) • Electronic Data Capture (EDC): Phase Forward, Oracle, CMed, INFORM, Medidata/RAVE, & Proprietary EDC Platforms • Clinical Trial Maintenance Systems & eTMF Platforms: Veeva Vault, Trial Interactive, TransPerfect/eClinical, Medidata/RAVE CTMS, TrialWorks, MFiles & Proprietary CTMS & eTMF Platforms • Interactive Web Response Systems: Suvoda, ClinPhone Randomization & Trial Supply Management • Vendor Management & Training Systems: Firecrest & GreenPhire • Project-Specific/Shared Drives: SharePoint, BOX, & TEAMSI’m always open to connecting with other professionals and exploring new opportunities for collaboration on innovative clinical research projects. Let’s make an impact together!

Experience

1. Principal Clinical Lead

   Premier Research

   Feb 2025 — Present

Education

• Texas Woman's University

  Masters of Science, Social Sciences

• University of North Texas

  Bachelor of Arts (B.A.), Sociology

Skills

• Clinical Operations
• Clinical Research
• Regulatory Affairs
• Gcp
• CRO
• Oncology
• Protocol
• Ich-Gcp
• Clinical Monitoring
• Edc
• Ctms
• Operations Management
• Clinical Development
• Clinical Trials
• Pharmaceutical Industry
• Sop