Almut M. - Freelance Project and Supply Manager

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Ranschbach, Germany

Experience

May 2024 - Present

1 year 4 months

Remote

Freelance Clinical IMP and Supply Manager (CAR-T cells)

Biotech

Task list (excerpt):

First point of contact for IMP questions of clinical site staff on behalf of the sponsor
Contribution to apheresis site audits and establishing leukapheresis documents for clinical trials
Oversight of IMP and comparator life cycle from receipt to destruction, including manufacturing, release, packaging, labelling, distribution, and IxRS set-up
Consultation on implementing IMP-related processes for the clinical supply chain
Development and surveillance of manuals and working procedures for IMP management
Authoring instructions for manufacturers, ordering of fresh/frozen IMP, thawing methods, administration at clinical sites, contribution to other IMP-related documents
Documentation and escalation of IMP deviations and issues to all stakeholders and ensuring completion of preventive and corrective actions
Coordination of activities for procedures associated with IMP quality with regards to practical feasibility at all involved parties together with subject matter experts, qualification, training and compliance checks of contract manufacturers in collaboration with QA
Alignment of processes for the use of products with parameters outside their specification
IMP-trainings of internal and external team members including onboarding
Responsible for naming conventions and adequate filing of all IMP-related documents in TMF and ISFs
Continuous improvement by establishing communication plans and other supporting documents for lymphoma studies, including paediatric trials
Review of all SOPs and other IMP handling documents
Hosting Teams meetings and attending relevant other meetings of sponsor and service providers

Summary

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
Dr. med. vet; 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)