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.
Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team. In this role, you will:
- Lead successful and timely operational execution of global insourced or outsourced, Non-Registrational Data Generating or Registrational Data Generating interventional clinical trials from concept to final clinical study report
- Act as the primary operational contact for the study and leads the cross- functional global team for execution of the study
- May provide quality oversight of one or more Contract Research Organization (CRO) teams and vendors
- Focuse on project management concepts to support management of issues, risks, timelines, and budget and ensures quality compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WP
- Direct and delegate to assigned Global Trial Management staff as applicable
- Drive study execution utilizing available performance metrics and quality indicators (e.g. CTMS, eTMF reports, RBM reports), and study milestones and drivers
- Develops manage, and maintain study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions
- Proactively identify potential risks, develops/implements actions, and makes the appropriate trade-offs of balancing risks with study deliverables and costs
- Maintain and update data as appropriate in project management tools including CTMS
- Lead Study Team meetings, define the agenda, capture meeting minutes, and facilitate cross-functional discussions
- Create, maintain, and implement project management tools at the study level (e.g. actions, decisions, issues log and risk management plan)
- P rovides strategic input into Study Team - e.g., on study document
- Collaborate with CSO on global investigational product [IP] supply forecasting/management
- Participate in the subject recruitment/retention strategy and related initiatives (e.g. recruitment material).
- Participates in clinical service provider (vendor) selection, specification development, and management / oversight.
- Oversees TMF set-up, ongoing quality review, and operational oversight memo and requests final reconciliation
- Oversees eCOA activities throughout the lifecycle of the study.
- Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.
- Oversee study specific CSR appendices
- Lead Audit Response Team and CAPA and participate in inspections.
- Support the development/management/review of the vendor scope of work (SOW), invoices, accruals as per the contract, quality requirements, and budget
- Review/approve functional plans (e.g. SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements with BMS)
- Set up and maintains Protocol Level training curriculum in SuccessFactors
- Proactively develop/maintain collaborative relationships with internal partners/stakeholders across the multidisciplinary teams
- Manage external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable
- Create realistic plans that clearly define goals, milestones, responsibilities, and results
- Bachelor or Master in Sciences
- Minimum 4 years of demonstrated project management experience of which at least 2 should have been in the pharmaceutical or healthcare industry
- 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. Experience in managing CROs is a plus
- Financial budgeting and forecasting skills are a plus
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
- Proven success in using oral/written communication skills to influence, inform, or guide others
- Proficiency in study tools including electronic system skills - e.g. CTMS/eTMF
- Ability to manage multiple deliverables and nimbly respond to changing business demands
- You have critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines
- Adaptable and flexible-willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism
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.