Jonathan Likowski

About Jonathan Likowski

24 years oncology clinical research experience in a CRO, Pharmaceutical and Biotech setting.Throughout my career I\'ve managed operations of Phase I-IV clinical trials. Worked with multiple department leads and vendors to identify and evaluate study progress and project potential safety, enrollment, data issues that could potential affect the efficiency of the study. Vast experience in program development and study progression. My experience includes Phase I-IV studies from Site Evaluation, Regulatory Development, Site Selection, Subject Recruitment, Subject Enrollment, Data Collection, and Database Lock through up until FDA Submission. Worked both in house and remotely within large, midsize and small CROs. I pride my work as a detailed and result oriented CRA conducting Clinical Trials, instrumental in risk identification and mitigation, managing and conducting clinical trials, developing internal and external client relationships with the PIs and site staff. SPECIALTIES: Project Management, KPIs, Deliverables, Communication/Presentation, Training/Mentoring transitioning team members, Risk Mitigation, Site Budget Negotiation, and Customer Relations including EDC, IVRS, PK, Central Lab, IP Accountability, Monitoring Plan, SAE Reporting tracking and Regulatory tracking/training. I’ve been involved in developing Clinical Operations, Process Improvement Plans, Developing Project Specific Plans and Tools to assist in project efficiency. My responsibilities have also included developing Data Management/Query Resolution plans, CRF proficiency, ICH/GCP Adherence along with Company and site SOP Adherence.GOALS: My career goals are to work as an integral member of a team and business unit. To work efficiently and accurately across all functions of clinical trials ensuring that our study team meets our deliverables.

Experience

1. Clinical Project Manager

   IQVIA

   Dec 2024 — Present · VA, US

Education

• University of Mary Washington

  Bachelor's of Science, Business Administration and Management

  1997 — 2001

Skills

• Lupus
• Pharmaceutics
• Clinical Trials
• Html
• Clinical Development
• CRO
• Regulatory Affairs
• Ccra
• Acrp
• Clinical Monitoring
• Clinical Operations
• 21 Cfr Part 11
• Medical Devices
• Clinical Research
• Ich-Gcp
• Oncology Clinical Research
• Regulatory Requirements
• Common Variable Immune Deficiency
• Inform
• Css
• Life Sciences
• Sepsis
• Hemphillia (Factor Viii)
• Drug Development
• Gcp
• Cardiology
• Edc
• Ctms
• Validation
• Recurrent Stroke
• Infectious Diseases
• Research
• Microsoft Office
• Pharmacovigilance
• Pain Device
• Management
• Orthostatic Hypotension
• Regulatory Submissions
• Illustrator
• Pharmaceutical Industry