Senior Specialist, Clinical Trial Associate - Munich, Deutschland - Bristol Myers Squibb

Bristol Myers Squibb

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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.

Position Profile:

Setting up vendors during study start up period (operational details from sites)
Enter necessary data / tracking in systems (i.e. CTMS, SIP, eTMF, SAP)
Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like Shared Investigator Portal) including conduct of completeness checks
Arranging drug and nondrug (Lab kits, ECG) importation to support study site
Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO
Collect and distribute documents from / to sites during study life cycle
Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation
Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding
Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)
Obtain Insurance certificates
Preparing On Site Investigator File and other study related files
Support equipment calibration and tracking
Archiving process handling at study closure
May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.
May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)
May support Health Authority inspection and preinspection activities
May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

Qualification:

Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred
Basic understanding of GCPs, ICH Guidelines and local regulations as they apply.
Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
Demonstrates ability to function independently
Good verbal and written communication skills (both in English and local language).

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to
work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

LI-Hybrid

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.