Julia Collins
Clinical Operations Director
- Role
- Director at Exegi Pharma, Llc
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Julia Collins
Experienced Clinical Operations leader with over 15 years of clinical research experience within study site, CRO and biotech sponsor environments (Phases Proven leader and highly skilled in clinical development strategy, strategic operational planning, vendor governance, cross-functional team management, protocol document and informed consent development, timeline and budget development/management, vendor and site contracts, site selection and management, study start-up, clinical and safety monitoring, database development and management, Trial Master File, regulatory affairs and communication, investigational product and study supply procurement and management, study closeout, clinical study reports, and scientific publications. Additional skills in program management, training coordination and quality management (e.g, cGMP, cGCP). Therapeutic experience in Neurology, Gastroenterology, Rare Disease, Substance Use Disorders, Infectious Disease, Cardiology, Cardiac Surgery and Sleep Medicine. Special interest in Neurological and Psychiatric disorders.
Experience
Director
Dec 2023 — Present · US
Serve as Director of Clinical Operations by leading the company\'s clinical development program, including operational planning and execution, for a novel live biotherapeutic product (Phase 1b/2). Oversee company projects, programs, and quality.
Education
University of Maryland, Baltimore (UMB)
Master of Science - MS, Regulatory Science, Summa Cum Laude
Northeastern University
Bachelor of Science - BS, Behavioral Neuroscience, Summa Cum Laude
Skills
- Clinical Research
- Clinical Trials
- Human Subjects Research
- Pharmaceutical Research
- Irb
- Phlebotomy
- Endnote
- Eeg
- Neuroscience
- Clinical Data Management
- Data Analysis
- Protocol
- Gcp
- Microsoft Office
- Research
- Molecular Biology
- Medicine
- Life Sciences
- Cell Culture
- Powerpoint
- Institutional Review Board (Irb)
- Good Clinical Practice (Gcp)
- Electronic Data Capture (Edc)
- Public Health
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