Senior Global Trial Manager Early Development and Cell Therapy (R1559501-en-us)
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.
The Senior Global Trial Manager, Early Development & Cell therapy:
Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
Independently leads complex, large, global in-house or outsourced, Early Development Registrational trials at any point in their life cycle.
Acts as the primary operational contact for the study and leads the cross-functional global team for execution of the trial.
May provide operational leadership of one or more cross-functional Study Team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Has high global organizational impact and influence, and significant impact on function and Study Team.
Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:
Leads and drives collaboration with the Study Team for trial operational delivery to ensure expected timelines, budget, and quality standards of BMS are met,
Develops, manages, and maintains study deliverables (i.e. timelines, study plans, goals, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.
Displays a sense of urgency on obtaining results with an emphasis on high quality outcomes, utilizing available performance metrics and quality indicators and study milestones and drivers, making timely decisions incorporating global considerations.
Displays critical thinking, problem solving, strategic thinking skills to drive the study(ies,) and sets and manages expectations.
Has command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of BMS (as appropriate).
Proactively identifies potential risks, develops/implements actions, and makes the appropriate trade-offs of balancing risks with study deliverables and costs.
Owns overall and end-to-end study project management responsibilities
Study Planning and Conduct
Provides strategic input into Study Team e.g., on study documents and reviews/approves functional plans.
Reviews study planning and tracking tools regularly (including study budgets), flags concerns to relevant stakeholders, and develops mitigation plans.
Provides input to data, protocol deviation review, and patient tracker.
Participate in clinical service provider (vendor) selection and management,
Provides oversight and relevant information to the CRO and reviews CRO deliverables for outsourced studies.
General Leadership Competencies
Ability to effectively lead a cross-functional team in a matrix environment.
Acts as a mentor for the Study Team and function
Develops and promotes strong collaborative relationships across teams, functions, and globally dispersed colleagues.
Effectively uses oral/written communication skills to influence, inform, or guide others.
Seeks opportunities for continued learning as to how strategy is shaped in the organization, fosters a continuous learning mindset.
Is adaptable and willing to adjust to multiple demands and shifting priorities
May participate in company initiatives, leads continuous improvement initiatives, and shares knowledge where applicable.
Qualifications & Experience:
BA/BS or equivalent degree in relevant discipline
Minimum 6 years of clinical study management experience of which at least 2 years should have been in direct multinational study management.
Experience in leading global clinical trials and multi-functional teams.
Demonstrated project management and organizational skills with strong presentation and communication abilities.
Experience with electronic quality, compliance and CTMS systems.
Risk management experience preferred.
Experience in managing CROs is a plus
Key Technical Competency Requirements
Expert level cross functional awareness.
Expert knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint
Proficiency in study tools including electronic system skills e.g. CTMS/eTMF
Financial budgeting and forecasting skills are a plus.
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.