Senior Clinical Project Manager; m​/w​/d; Remote

Location:

Germany

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

• 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

A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an…