20 beste Stellen als clinical project in münchen, by – aktuell auf Personalsuche

Clinical Research Associate - Germany
Linical —München
- Hybrides Arbeiten
- Management-Erfahrung
- Englisch
- Forschungserfahrung
Study Start Up Associate
Alira Health —München
- Vollzeit
- Microsoft Office
- Bachelor
FSP Project Coordinator with Budget & Finance expertise based in Munich
Fortrea —München
- Vollzeit
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
13 Tage
Clinical Research Associate
Alexion Pharmaceuticals,Inc. —München
- Bachelor
- Mit Reiseanteil
- Kommunikationsfähigkeit
Senior Clinical Trial Coordinator
Alira Health —München
- 40.000 € – 50.000 € pro Jahr
- Vollzeit
- Kundenberatung
- Forschungserfahrung
- Microsoft Office
Clinical Project Manager (all genders)
Avelios Medical GmbH —München
- Vollzeit
- Projektmanagement
- Mit Reiseanteil
Project Assistant (m/f/d)
Argenta —München
- Vollzeit
- Englisch
- Microsoft Office
Direkt bewerben
Scientific Coordinator (m/f/d)
TUM Klinikum Rechts der Isar —München
- Teilzeit
- Doktorat
- Forschungserfahrung
- Mit Reiseanteil
Regional Medical Advisor (m/f/d) – HIV (Berlin & Eastern Germany)
GlaxoSmithKline —München
- 90.000 € – 150.000 € pro Jahr
- Vollzeit
- Mit Reiseanteil
6 Tage
Projektleiter / Project Manager Clinical Trials
FUTRUE —Gräfelfing
- Vollzeit
- Microsoft Powerpoint
- Microsoft Excel
- Englisch
Direkt bewerben
Clinical Research Associate I - Real World Late Phase
サイネオス・ヘルス —München
- Bachelor
- Wirtschaft
Medical Consultant (all genders)
Avelios Medical GmbH —München
- Vollzeit
Clinical Project Manager (all genders)
Avelios Medical —München
- Vollzeit
- Projektmanagement
- Mit Reiseanteil
Research Assistant Molecular Medical Microbiology (MLA/BTA/VMTA, B.Sc./M.Sc. Molecular or Medical Microbiology)
Max von Pettenkofer-Institut —München
- Teilzeit
- Laborerfahrung
- Englisch
- Master
Clinical Research Associate / Senior CRA
Edwards Lifesciences —Garching bei München
- Vollzeit
- Englisch
- Forschungserfahrung
- Microsoft Office
- Kostenbeteiligung am Arbeitsweg
- Flexible Arbeitszeiten
Business Development Analyst (m/w/d)
AniCura Group —München
- Vollzeit
- Hybrides Arbeiten
- Microsoft Excel
- Finanzwirtschaft
- Master
Medical Projects Manager [Germany] (m/f/d)
AniCura Deutschland —Unterhaching
- Vollzeit
- Hybrides Arbeiten
- Projektmanagement
- Führungserfahrung
- Flexible Arbeitszeiten
Program Manager, Digital Solutions (m/f/d)
Abbott Laboratories —München
- Vollzeit
- Microsoft Excel
- Oracle
- PMP
Medical Project Manger [Germany]
AniCura Group —München
- Vollzeit
- Hybrides Arbeiten
- Projektmanagement
- Führungserfahrung
- Flexible Arbeitszeiten
Ready to Make a Bigger Impact? Join Us as Our Business Development Leader for Germany & Austria.
Eurofins Germany PSS —München
- Vollzeit
- Homeoffice
- Unternehmensentwicklung
- Produktion
- Wirtschaft
Direkt bewerben

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Clinical Research Associate - Germany

Linical -
München

Jetzt bewerben

Details zur Stelle

Qualifikationen

Management-Erfahrung
Englisch
Forschungserfahrung
Deutsch
Zeitmanagement

Vollständige Stellenbeschreibung

The Clinical Research Associate is responsible for the feasibility, initiation, monitoring, and close-out of investigative sites.

Major responsibilities include ensuring the safety and well-being of study participants at assigned sites, ensuring site compliance with Good Clinical Practice (GCPs), applicable regulations, the protocol and study plans; ensuring data integrity through source data verification and monitoring process, and ensuring site compliance with all Investigational Product (IP) storage, inventory, dispensing, dosing, and disposition requirements.

EU CRAs could have a shared role of Regulatory Affairs Officer (RAO) and CRA. The Regulatory department will oversee the RAO role while the Clinical Operations Manager (COM) will oversee the CRA role.

Duties and Responsibilities

Participates in the identification of potential investigative sites, conducts site qualification visits, collects, and reviews site regulatory documents, and prepares site qualification visit reports and associated documentation; participates in the final selection of investigative sites
Conducts site initiation visits; trains site personnel on Client and regulatory requirements for study conduct; participates in and/or conducts site meetings and investigator meetings, and prepares site initiation visit reports and associated documentation
Conducts site monitoring visits and follow-up to identify significant problems and issues, and to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations; prepares monitoring visit reports and associated documentation
Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required
Assists in submissions to the Independent Ethics Committees (central and local) and to Competent / Regulatory Authorities
Arranges site payments and facilitates site budgets and contracts as requested
Ensures training is performed within a reasonable period and is current and appropriately documented
Ensure protocol deviations are appropriately documented, and action items are followed through to completion
Manages site monitoring visit schedule, and the follow-up of issues between visits, along with ongoing regular communication with the sites and the clinical study team
Maintains close contact with the site staff, to be aware of patient enrolment, enrolled patients’ status, IP supply and any further site requests or issues
Ensures essential documents are filed in the Trial Master File (TMF) according to the project guidelines
Ensures appropriate and timely transmission of clinical data to data management; reviews data queries, and clarifies and/or obtains changes to data as appropriate
Conducts site close-out visits to include final IP reconciliation and disposition, review of completeness and accuracy of files, and retrieval of documents for the TMF; prepares site close-out visit reports and associated documentation
Attend team meetings as required
Participates in systems User Acceptance Testing as required
Senior CRA assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in development of participant tracking systems; conducts monitoring assessment visits for the purpose of rescuing a troubled site or performing audit preparation at the direction of the CTM
Senior CRA oversees work for assigned CRAs on a designated project; reviews and approves monitoring visit reports; manages the visit schedule; provides feedback during the annual review process regarding performance of assigned CRAs
Other duties as assigned

Required Skills and Abilities

Require a minimum of four years’ clinical research experience (e.g., Clinical Trial Associate, Study Coordinator) or equivalent.
Life Science degree or equivalent experience combined with successful completion of a recognized CRA training program is essential
Requires a minimum of two years’ monitoring and site management experience as Clinical Research Associate
Pulmonology and Oncology therapeutic expertise
Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs, and the scientific/clinical knowledge to be able to understand the nature of drugs being studied
Excellent written and verbal communication skills, and time management, organizational and problem-solving skills
Fluent in German language (speaking, writing) and good comprehension of English language where English is not the local language
Excellent people skills and ability to work successfully in a matrixed team environment
Dedication to quality in all work tasks and deliverables
Ability to prioritize and manage multiple tasks as necessary, including during travel and monitoring visits
Working knowledge of computer systems, applications, and operating systems
Ability to travel up to 75%
Possess a valid driver’s license, as required

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Erweiterte Suche

clinical project Jobs in münchen, by

Clinical Research Associate - Germany

Study Start Up Associate

FSP Project Coordinator with Budget & Finance expertise based in Munich

Clinical Research Associate

Senior Clinical Trial Coordinator

Clinical Project Manager (all genders)

Project Assistant (m/f/d)

Scientific Coordinator (m/f/d)

Regional Medical Advisor (m/f/d) – HIV (Berlin & Eastern Germany)

Projektleiter / Project Manager Clinical Trials

Clinical Research Associate I - Real World Late Phase

Medical Consultant (all genders)

Clinical Project Manager (all genders)

Research Assistant Molecular Medical Microbiology (MLA/BTA/VMTA, B.Sc./M.Sc. Molecular or Medical Microbiology)

Clinical Research Associate / Senior CRA

Business Development Analyst (m/w/d)

Medical Projects Manager [Germany] (m/f/d)

Program Manager, Digital Solutions (m/f/d)

Medical Project Manger [Germany]

Ready to Make a Bigger Impact? Join Us as Our Business Development Leader for Germany & Austria.

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