(Associate) Clinical Trial Monitor, Cra
vor 2 Wochen
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
**Responsibilities**
- Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
- While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
- Serve as a point of contact for Sites and develops site relationship
- Provides trainings to sites.
- Performs site selection, initiation and closure activities.
- Manages multiple protocols, across multiple therapeutic areas
- Ensures completeness and quality of data submitted from study sites.
- Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.
- Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.
- Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
- May support Ethics Committee submission, ICF review, collection of documents to/from site.
- May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel.
- support coordination and ensure database lock timelines are met as required locally.
**Requirements**:
- Bachelors required preferably within life sciences or equivalent.
- Good verbal and written communication skills (both in German and English)
- 2 or more years of relevant clinical research experience, able to work independently.
- Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred (CRA, CRC, etc.)
- Experience in the drug discovery/development process.
- Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
- Knowledge and understanding of clinical research processes, regulations and methodology
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Organization and time management skills.
- Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations
LI-Remote
Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.
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