Almut Malone-Freelance Project and Supply Manager

Key competences

• Fluency in English and German oral and written includes medical language specific to clinical research and good understanding of cultural differences due to extensive working and travel experience; world trip in 2008
• Highly self-organized, client- and solution-oriented; able to motivate and manage team
• Stringent with quality, budget and timelines; focused on patient safety
• Experience with assignments by large (i. e. Bayer, GSK, Novartis) as well as very small pharmaceutical and biotech companies and CROs
• Trained new staff of small CRO with no experience while meeting required timelines Short profile
• Doctor of Veterinary Medicine; Abundance of Experience with Monitoring since 1991, Freelance CRA since 1996, Sourcing of IMP and Supply Management since 2001, Clinical Study and Project Management since 2006, Temperature-controlled IMP Logistics since 2008, Designated Applicant in Germany since 2016.
• Submissions of cancer, immunology, pediatric and rare disease studies to health authorities and Ethics Committees in Germany, feasibility, investigator search and site set-up, vendor evaluation and selection, budget negotiation, forecast and control, CRO, CMO and IRT vendor oversight, optimization with significant cost savings, leading TCs with virtual teams across continents, project plan and implementation, co-monitoring, audit preparation and attendance with high quality awareness in all areas and interfaces of clinical trials.
• Fluent in English (father tongue) and German (mother tongue) with track record of translations for clinical trial documents. Summary of Indication Experience
• Cancer (breast, renal, colorectal, solid tumors, melanoma, prostate, bone, AML)
• Immunological (sepsis, MS, autoimmune diseases, vaccines)
• Rare diseases (MPS II, A1P1 deficiency, Fabry, Myasthenia gravis, CIDP)
• Pediatric diseases (hemophilia, growth hormone deficiency, venous thromboembolism)
• Cardiovascular (all indications, including stents and cryotherapy, chronic heart failure)
• Lung diseases (pneumonia, asthma, COPD)
• Brain (epilepsy, subarachnoid aneurysmal bleeding)
• Many other (insomnia, endocrine, medical devices)