NRDG Protocol Manager
- Tokyo, Japan
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
[Functional Area Description]
Provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research, crossing all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, Non-Regulatory Data Generation (NRDG) clinical research including Health Economics and Outcomes Research (HEOR), Investigator-Sponsored Research (ISR), Expanded Access Programs (EAP), and some local late-stage interventional research
[Position Summary / Objective]
• Manages simple protocols within a complex matrix environment for successful and timely operational execution of clinical research from start to end
• Demonstrates flexibility and manages studies across organization (i.e. multiple TAs) & different study types (i.e. NIR, Late Phase, ISR)
• Focused on project management concepts to support management of issues, risks, timelines and budget.
• Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams
• With the support from Senior Protocol Manager and Line Manager:
o monitor trial progress
o Address and manage obstacles
o Develop protocol-level documents and plans and training
o Identify issues and risks, escalating appropriately
o Oversee vendors
o Monitor study budget
o Manage and comply with various quality and compliance systems
• Associate Protocol Manager may have responsibility for lower activity clinical trials in the maintenance phase
2-4 years of demonstrated project management experience of which at least 1 should have been in the pharmaceutical or healthcare industry. Experience in execution of clinical trials demonstrating project management and organizational skills. CRO experience is a plus. CTMS and electronic trial master file a plus.
[Key Competency Requirements]
Basic project management acumen, effective communication
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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