Clinical Trials Specialist
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- auf Anfrage
- 81673 München
- Nähe des Wohnortes
- en
- 29.07.2023
Kurzvorstellung
departments in order to maintain integrity and completion of tasks on specified timeline.
Qualifikationen
Projekt‐ & Berufserfahrung
3/2021 – offen
TätigkeitsbeschreibungAid in financial management of trials, including invoicing reports to be billed to the sponsor; partner with research program manager, fiscal and research staff to conduct post-award budget analysis to improve system efficiency to increase revenue. Budget and contract negotiation during start-up and amendments.
Eingesetzte QualifikationenFakturier- / Mahnwesen, Finanzen (allg.), Good clinical practice (GCP), Good documentation practice (GDP, GDocP), Onkologie
3/2019 – 3/2021
TätigkeitsbeschreibungDirect supervision of 6 team members. Experience coordinating clinical trials, owning and creating source documentation to streamline processes. Collaborate with multiple departments in order to keep projects within timeline. Budget and contract negotiation during start-up and amendments.
Eingesetzte QualifikationenGood clinical practice (GCP), Good documentation practice (GDP, GDocP), Hämatologie, Klinische Studie, Management (allg.), Medizinforschung, MS Excel, Onkologie
6/2016 – 3/2019
TätigkeitsbeschreibungExperience with sponsor and FDA audits. Coordination of clinical trials, phase I - III. Working with physicians, nurses, technicians and other staff members to ensure protocol compliance in the face of obstacles. Communicating complex procedures to participants.
Eingesetzte QualifikationenGood clinical practice (GCP), Good documentation practice (GDP, GDocP), Hämatologie, Klinische Studie, Medizinforschung, Onkologie
4/2015 – 6/2016
TätigkeitsbeschreibungCoordinate multiple pre-clinical trials for oncologists and postdoctoral fellows specializing in hematology-oncology and immunology. Serve as a liaison between PI’s, postdoctoral fellows, pharmacy, research staff, veterinary services and lab technicians to maintain protocol integrity.
Eingesetzte QualifikationenGute Laborpraxis (GLP)
12/2012 – 12/2014
TätigkeitsbeschreibungPerform Lead research associate duties such as coordinating commercial pre-clinical trials from startup to completion, training new staff and ensure source document completion while adhering to study protocols and company standard operating procedures.
Eingesetzte QualifikationenGute Laborpraxis (GLP)
12/2012 – 12/2014
TätigkeitsbeschreibungOrganizing and performing procedures and sample collections for clinical trials. Identifying site issues and recommend corrective actions. Consent and communicating procedural risks with patients and subjects.
Eingesetzte QualifikationenGood clinical practice (GCP)
Zertifikate
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Weitere Kenntnisse
Persönliche Daten
- Englisch (Muttersprache)
- Europäische Union
- Vereinigte Staaten von Amerika
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