Astralis Consulting

Dynamic and pragmatic SME-owned boutique consulting firm with nearly 2 decades of experience providing services to start up, mid-size, and large Biotechnology and Pharmaceutical clients for global, Phase I-IV clinical trials. We present a unique opportunity to not only fulfill multiple functions, but all role leveling. We are passionate in supporting our client’s by bringing a multi-faceted, cross-functional, perspective! The SME-owner has served as the Head of five Clinical functions: Clinical Operations, Clinical Quality Assurance, Clinical Outsourcing, TMF Operations, and Global Inspection Readiness. We are also pleased to offer robust indication-specific knowledge and experience, which spans a wide range of therapeutic areas including, but not limited to: Rare Disease | Gene Therapy | Vaccines | Controlled Substances | Oncology | Ophthalmology | Infectious Disease | Neurology | Hematology | Immunology | Nephrology | Rheumatology | Gastroenterology | Psychiatry | Musculoskeletal | Cardiology | Vascular | Endocrinology | Reproductive System | CNS | Obesity Direct hire (C2C) or Contract Services include: ✅ Clinical Operations ✅ Clinical Quality Assurance ✅ Clinical Outsourcing ✅ TMF Operations ✅ Inspection Readiness ✅ GCP Auditing ✅ Institutional Review Board (IRB) ✅ SOP Development and Process Improvement ✅ GxP Computer Systems ✅ Global Regulatory Compliance ✅ CRO/Vendor Management/Governance ✅ CRO/Vendor Relationship Initiatives ✅ Gap Analysis/Risk Assessment ✅ Strategy Leadership & Planning ✅ Biotech/Pharma Career Coaching ✅ Biotech/Pharma Mentorship Contact Us: 📧: info@astralisconsultinggroup.com