With over 20 years of experience in clinical and scientific consulting, he excels in project management, quality assurance, and medical writing, making him a valuable asset for any clinical research team
Proven track record in managing complex clinical trials and non-interventional studies across various indications, including oncology and pain management, ensuring compliance and successful project delivery
Holds a doctorate in Molecular Cancer Research and has extensive experience in leading interdisciplinary collaborations, contributing to significant scientific publications and advancements in the field
Certified in quality management and project management, he brings a robust understanding of regulatory requirements and standards, enhancing the quality and efficiency of clinical operations
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Overview
- Availability
- 5 days/week, remote
- Qualification
- Doctorate in Molecular Cancer Research
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Senior Scientific Consultant, Drug Development Phases I-IV, NIS Study Documents, Medical & Scientific Writing, Publications, Investigator-Sponsored Studies, Study Protocols, GCP, EMA, BfArM, Oncology, Pharma
Key-Facts
Extract from previous activities
Biopharmaceutical Company, Germany (via K-Recruiting)
Scientific Consultant Oncology & Clinical Study Documents
Review of literature and publication, including written feedback reports
Provides expert up to date knowledge of oncology
International regulations, guidelines and requirements for global drug development
Medical information and marketing
Provides medical writing services for Clinical Study Protocols and Clinical Study Reports
Responsible for reviewing and finalizing clinical study documents (study protocol, CRF, Patient Information, and Informed Consent)
Organize submissions to Regulatory Authorities and Ethical Committees
Institute of Clinical Cancer Research, Germany
Senior Scientific Consultant / Interim Head of Quality Assurance Unit
Business Development/Budget Planning
Project Planning/Protocol Writing/Medical Writing
Contract Management
Sponsor Oversight, internal/external Audits
Leadership (disciplinary lead 1.5 FTEs, technical lead ~30 FTEs)
Indications: Oncology, Parenteral Nutrition
Pharmaceutical Company, Germany
Phase IV Manager Global Key Brands
Lifecycle Management of Global Key Brands
Managing the interface between internal units (e.g. Clinical Research, Pharmacovigilance, Regulatory, Market Access) and external vendors/CROs
Study Coordination (Budget Planning, Contracting, Performance reviews)
Indications: Allergy, Pain, Oncology
Pharmaceutical Company, Germany
Phase IV Manager and Manager Non-Clinical Research
Initiation, Conduct and Reporting of national and international PASS, PAES, DUS, Cohort Studies
Study Coordination (Budget Planning, Contracting, Performance review)
Oversight of Tox and Ecotox Study Programs
Indications: Allergy, Pain, Oncology