Greater Munich Metropolitan Area
With more than 20 years in oncology, I bring together the mindset of a scientist and the precision of a clinical research professional. For about 15 years, I worked in basic oncology research, publishing 15+ peer-reviewed papers — including first-author articles in top oncology journals — which shaped my critical thinking and deep understanding of cancer biology. During the past six years, I transitioned into clinical research and built comprehensive, hands-on expertise across the full operational spectrum — from Site Coordinator and Clinical Trial Administrator to In-house CRA, sponsor-dedicated CRA, and Site Manager. My experience spans all major trial phases (I–IV) and include oncology studies in bladder, colorectal, and lung cancer as well as leukemia — bringing my scientific background full circle into patient-focused research. I’m driven by curiosity, collaboration, and the ambition to move oncology forward — passionate about innovative therapies that turn scientific discovery into real clinical benefit. Frederik Wein's public Pubmed Bibliography: https://www.ncbi.nlm.nih.gov/myncbi/1ZYVmyYtTcD5y/bibliography/public/
Sponsor-Dedicated Clinical Research Professional with extensive monitoring and site management expertise, focused on late-phase Oncology trials (Phases III & IV). Core Therapeutic Experience and Indications: Bladder Cancer (BLC), Colorectal Cancer (COL), Acute Myeloid Leukemia (AML), Non-Small Cell Lung Cancer (NSCLC)
Detail-oriented Clinical Research Associate (CRA I) with hands-on experience across all major site visit types and clinical trial phases. Proven ability to manage complex protocols and ensure high-quality data collection and regulatory compliance. Proficient in conducting: • PSV (Pre-Study Visits) • SIV (Site Initiation Visits) • RMV (Routine Monitoring Visits) • COV (Close-Out Visits) • Oversight of Phase I–IV clinical trials Therapeutic Areas & Indications: • Vaccination / Immunization – Preventive and therapeutic vaccine trials • Urological Oncology – Studies in bladder and prostate cancer • Metabolic Diseases – Focused experience in Type 2 Diabetes Mellitus (T2DM); Phase I Experienced in working with cross-functional teams, ensuring GCP compliance, and maintaining strong site relationships. Ready to contribute to global clinical development programs with precision and integrity.
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaising with vendors; and other duties, as assigned • Responsible for all aspects of site management as prescribed in the project plans. • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review • Ensure audit readiness at the site level • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor as assigned • Independently perform CRF review; query generation and resolution against established data review guidelines on organization or client data management systems as assigned by management • Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, and narratives and follow up on SAE • Travel, including air travel, may be required and is an essential function of the job
• To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA • To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits • To perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on organization or client data management systems, as assigned by management • To assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples • To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines • To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment • To proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in the region • To demonstrate an understanding of the purpose of CTMS
Co-Authored Publications (peer-reviewed, PubMed): • Quality appraisal of systematic reviews, and meta-analysis of the hospital/surgeon-linked volume-outcome relationship of carotid revascularization procedures Kallmayer M, Salvermoser M, Knappich C, Trenner M, Karlas A, Wein F, Eckstein H, Kuehnl A The Journal of Cardiovascular Surgery (2019) 60(3) 354-363
Experienced clinical researcher and scientific communicator with a strong foundation in oncology and hematologic malignancies. Demonstrated expertise in: Co-Authored Publications (peer-reviewed, PubMed) • Notch Signaling Mediates Differentiation in Barrett’s Esophagus and Promotes Progression to Adenocarcinoma Bettina Kunze *, Frederik Wein *, ... Michael Quante; * F. Wein and B. Kunze share co-first authorship Gastroenterology. 2020 Apr 20; S0016-5085(20)30516-3. doi: 10.1053/j.gastro.2020.04.033. Impact Factor of 19.809. • BarrettNET—a prospective registry for risk estimation of patients with Barrett's esophagus to progress to adenocarcinoma Wiethaler M, Slotta-Huspenina J, Brandtner A, Horstmann J, Wein F, et.al. Dis Esophagus. 2019 Aug 1;32(8). pii: doz024. doi: 10.1093/dote/doz024. • High-Fat Diet Accelerates Carcinogenesis in a Mouse Model of Barrett’s Esophagus via Interleukin 8 and Alterations to the Gut Microbiome Gastroenterology. 2019 Aug;157(2):492-506.e2. doi: 10.1053/j.gastro.2019.04.013.Epub 2019 Apr 15.
Experienced clinical researcher and scientific communicator with a strong foundation in oncology and hematologic malignancies. Demonstrated expertise in: - Scientific Writing & Editing: Development of peer-reviewed publications, grant proposals, and study protocols - Academic Presentations: Delivery of research findings at international conferences and institutional seminars - Teaching & Mentorship: Instruction in immunology, cancer biology, and translational research topics Thanks for sharing this impressive list, Frederik! Here's a polished and professional version of your description and qualifications, with clear emphasis that the listed publications are selected highlights: Professional Profile – Clinical Research & Scientific Communication Experienced clinical researcher and scientific communicator with a strong foundation in oncology and hematologic malignancies. Demonstrated expertise in: - Scientific Writing & Editing - Academic Presentations - Teaching & Mentorship Selected Peer-Reviewed Publications (PubMed Indexed) The following represent key publications co-authored in high-impact journals, highlighting contributions to tumor immunology, cancer cell biology, and microenvironmental research: - Complex Immune Evasion Strategies in Classical Hodgkin Lymphoma Cancer Immunol Res. 2017 Dec;5(12). doi: 10.1158/2326-6066.CIR-17-0325 - The Role of T Cells in the Microenvironment of Hodgkin Lymphoma J Leukoc Biol. 2016 Jan;99(1):45–50. doi: 10.1189/jlb.3MR0315-136R - Potential Role of Hypoxia in Early Stages of Hodgkin Lymphoma Pathogenesis Haematologica. 2015 Oct;100(10):1320–6. doi: 10.3324/haematol.2015.127498 A complete list of publications is available upon request.