Sr Clinical Trial Planning Specialist III
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.
Clinical Trial Planning & Execution is a core GCO team responsible for governed country and site allocation and driving the adoption of a clinical trial planning capability and operating model to support Study Management Teams and GDO TA pillars in cross-functional, study-level project planning and management
GDO Sr. Clinical Trial Planning Specialists are responsible for building and tracking of clinical trial execution plans (phase I-IV) for the Global Development Operations (GDO) organization through project management tools (e.g, Microsoft Project) for Phase I-IV clinical trials.
- Detailed clinical trial execution plans (phase I-IV) for Global Development Operations (GDO) starting with portfolio and asset governance support and managed through CSR finalization.
- Study and cross-asset/indication critical path analyses to drive optimization of trial planning, country allocation & feasibility, and assessment of risks to trial delivery
- Collaborate with Study Management Teams to monitor delivery of clinical study milestones. Identify gaps and risks in the study plans and collaborate to develop solutions that will increase efficiency and minimize timelines.
- Monitoring overall study health and ensure risks and issues are evaluated and appropriately captured in systems and tools
- Capturing of risks, mitigations, resolution and escalation of issues and status.
- Providing regular study or program status reports to key GCO, Study Team and governance stakeholders consistent with established processes and best practices.
- lead initiatives or working groups to evolve project planning tools, processes and best practices
- Mentoring and matrix oversight of Clinical Trial Planning Specialists in areas of subject matter expertise or in support of study planning in assigned programs
A minimum of a Bachelor’s degree in Engineering, Pharmacy, science, technical discipline, or allied business function
At least 7 years clinical trial operations project management experience is required, with at least 3 years of direct experience in end-2-end clinical trial project management supporting trials in start-up, execution and close-out (DBL to CSR) activities
Key Competency Requirements
- Expert understanding of the end-to-end clinical trial planning and execution process
- Expertise with Clinical Trial Management System (CTMS) and Portfolio Management systems (e.g., Planisware) milestone and driver tracking
- Expert Proficiency (5 year +) with Microsoft Project
- Proficiency with other Microsoft tools, e.g. Excel, PowerPoint, SharePoint
- Strong analytical and communication skills to identify, report and escalate risks
- Ability to achieve results across a global matrix organization
- Ability to work independently with high level of accountability
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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