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About the Role
Working within the Global Clinical Affairs (GCA) organization, the Senior Clinical Project Manager is responsible for clinical trial management of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCA or Contract Research Organizations (CRO). The Senior Clinical Project will also serve as mentor to other Clinical Project Managers and CRA’s. This role serves as the project lead for multiple studies of high complexity from protocol development through study conduct and close out in compliance with Good Clinical Practices, and all Global, National and Local Regulations. Reports to and collaborates with the Clinical Program Manager and Director, OUS Clinical Affairs to review business requests and evaluate or develop early plans and concepts for optimal study execution.
Furthermore responsibilities in Detail:
With limited supervision, serve as Senior Clinical Project Manager in complex clinical trials Ensures execution within overall study timelines and deliverables and delivers accordingly for his/her studies.
Proactively identifies, escalates and manages risks and issues to ensure cost-effective timely delivery of the project Collaborates actively with other GCA functions, e.g. global project management, as applicable, DM and Statistics Collaborates with the Medical Affairs departments of the BD Business Units Oversees/leads and trains study-specific local clinical resources, e.g. contractor CRA, CRO, etc.
Provides critical thinking and escalates accordingly when issues arise during execution of clinical studies.
Oversees study quality and implements high quality standards in order to meet compliance requirements Contributes to continuous improvement activities/initiatives, Manages relationships with sites/PIs and other study-related vendors, e.g. CROs, central labs, etc.
Develop and/or oversee the development of clinical study budgets, including invoice review/approval and monthly accruals
Defines, tracks and reports on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff
About You
Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas
Minimum of 4 years project management experience
Minimum 6 years of clinical study experience, (e.g., preferably in medical device, or in IVD, pharmaceutical, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies
Familiarity with CLSI guidelines and other standards Demonstrable Project Management skills; PMP Certification is a preferred goal for all Clinical Project Managers; Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR and current industry practices related to the conduct of clinical studies Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations Strong client and vendor relationship management skills Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced and changing environment Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences Ability to work effectively in a virtual environment Ability to travel approximately 20%, worldwide
Our Offer
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
BD ist eines der größten internationalen Medizintechnologie-Unternehmen, das sich den Fortschritt für die Welt der Gesundheit durch Verbesserungen in den Bereichen der medizinischen Forschung, der Diagnostik sowie bei der Behandlung und Pflege von Patienten zum Ziel gesetzt hat. Das Unternehmen entwickelt innovative Technologien, Dienstleistungen und Konzepte, die helfen, die Versorgung der Patienten sowie die Abläufe im klinischen Alltag zu verbessern. Weltweit beschäftigt BD 70.000 Mitarbeiter und Mitarbeiter und ist in fast allen Ländern vertreten, um den drängendsten Herausforderungen bei der Gesundheitsversorgung zu begegnen. BD unterstützt seine Kunden dabei, bessere klinische Ergebnisse zu erzielen, Kosten zu senken, die Effizienz in Klinik und Labor zu erhöhen, die Patienten- und Anwendersicherheit zu verbessern sowie den Zugang zur Gesundheitsversorgung zu verbessern. bd.com
