Bayer ist ein weltweit tätiges Unternehmen mit Kernkompetenzen auf den Life-Science-Gebieten Gesundheit und Agrarwirtschaft. Als Innovations-Unternehmen setzt Bayer Zeichen in forschungsintensiven Bereichen. Mit seinen Produkten und Dienstleistungen will Bayer den Menschen nützen und zur Verbesserung der Lebensqualität beitragen. Bayer schätzt die Leidenschaft seiner Mitarbeiterinnen und Mitarbeiter für Innovationen und gibt ihnen die Kraft, Dinge zu verändern.

Manager, Institution Sponsored Collaborative Studies

YOUR TASKS AND RESPONSIBILITIES

• Manages all planning and execution activities in support of assigned studies within the Institution Sponsored Collaborative Studies (ISCS) group, a Data Generation program within the Medical Affairs Oncology SBU.


• Assists PM Lead in organizing the cross-functional review of study protocols, budgets, Informed Consents, CRFs, database structure, and other study management plans.


• Supports PM Lead in ensuring internal project-related activities and/or interactions with study sponsors comply with applicable guidelines and regulations governing externally sponsored studies.


• Supports PM Lead in ensuring assigned projects are resourced properly and executed within budget tolerances and in accordance with established timelines and quality expectations.


• Assists PM Lead in managing internal stakeholder expectations for assigned studies (e.g., information requests from strategic committees, study update meetings for country Medical Affairs advisors and/or MSLs, etc.).


• Assists PM Lead in processing required approvals for assigned studies at governance committees (e.g., concepts, protocols, budgets, etc.).


• Assists PM Lead in managing interactions with study sponsors, ensuring appropriate internal cross-functional representation for any given project topic.


• Assists PM Lead in managing project core and extended team interactions for assigned studies in order to align on recommendations and requests for study sponsors.


• Assists PM Lead in coordinating cross-functional efforts during transfers of study data for quality assurance measures and regulatory initiatives.


• Assists PM Lead in assessing risks and obstacles to study performance and provides options for resolution.


• Contributes to group, departmental, and/or organizational process improvement initiatives.


• Assists PM lead in overseeing any activities outsourced to CROs and/or vendors.


• Provides support and coverage for other Data Generation programs within the Operational Excellence & Project Management group if assigned.

WHO YOU ARE

• A Master’s degree with a minimum of 2 years’ experience in clinical research (e.g., Study Management, Project Management, Clinical Research Science, CRA/Monitoring, and Study Site Management) or a Bachelor's degree with a minimum of 4 years’ experience.


• A minimum of 2 years’ experience in oncology is required.


• Experience working in cross-functional project teams that for example included representation from Medical Affairs, Regulatory, Pharmacovigilance and/or Clinical Development.


• Demonstrated understanding of ICH/GCP and US/EU regulations governing clinical trials.


• Strong written, computer, and communication skills are required.

We are looking forward to receiving your application by 30th April. Thank you!

#LI-CH

Ihre Bewerbung

Sie suchen eine Herausforderung, in der Sie Ihre Leidenschaft für Innovationen einbringen können? Sie möchten Teil eines globalen Teams werden und gemeinsam mit uns das Leben auf der Welt verbessern? Dann bewerben Sie sich online mit Ihren vollständigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse).

Bayer begrüßt Bewerbungen aller Menschen ungeachtet von ethnischer Herkunft, nationaler Herkunft, Geschlecht, Alter, körperlichen Merkmalen, sozialer Herkunft, Behinderung, Mitgliedschaft in einer Gewerkschaft, Religion, Familienstand, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität oder einem anderen sachfremden Kriterium nach geltendem Recht. Wir bekennen uns zu dem Grundsatz, alle Bewerberinnen und Bewerber fair zu behandeln und Benachteiligungen zu vermeiden.

Land: Schweiz
Standort: Basel
Referenzcode: 159185
Funktionsbereich:Medical Affairs & Pharmakovigilanz

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