Global Trial Manager, Early Development and Cell Therapy (R1559212-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.
Global Trial Managers, crossing all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, global clinical research studies from concept to final clinical study report
Leads successful and timely operational execution of global insourced outsourced, Non-Registrational Data Generating or Registrational Data Generating interventional clinical trials from concept to final clinical study report.
Acts 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.
Focuses 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/WPs.
Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.
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:
Directs and delegates to assigned Global Trial Management staff as applicable.
Drives study execution utilizing available performance metrics and quality indicators (e.g. CTMS, eTMF reports, RBM reports), and study milestones and drivers.
Develops, manages, and maintains 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 identifies potential risks, develops/implements actions, and makes the appropriate trade-offs of balancing risks with study deliverables and costs.
Maintains and updates data as appropriate in project management tools including CTMS.
Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and recruitment status and raises potential issues/mitigation.
Requires minimal oversight to lead/manage projects.
Version 1.0 Employee Job Profile – Job Description
Identifies, participates and/or leads initiatives with cross-functional/global teams.
Leads Study Team meetings, defines the agenda, captures meeting minutes, and facilitates cross-functional discussions.
Creates, maintains, and implements project management tools at the study level (e.g. actions, decisions, issues log and risk management plan).
Study Planning and Conduct – Insourced Studies
Provides input to data, protocol deviation review, and patient tracker.
Provides strategic input into Study Team – e.g., on study documents.
Collaborates with CSO on global investigational product [IP] supply forecasting/management.
Participates 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.
Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.
Promptly shares information with key internal/external stakeholders at regular meetings.
Proactively identifies and anticipates issues and risks and oversees the creation of mitigation plans and implements resolutions.
Oversees service providers with minimal supervision.
Leads Audit Response Team and CAPA and participates in inspections.
Supports the development/management/review of the vendor scope of work (SOW), invoices, accruals as per the contract, quality requirements, and budget.
Study Planning and Conduct – Outsourced Studies
Reviews/approves functional plans (e.g. SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements with BMS).
Provides information to the CRO and reviews CRO deliverables. Sets up and maintains Protocol Level training curriculum in SuccessFactors.
Reviews Protocol Level training for IM and SIV.
Owns overall and end-to-end study project management responsibilities.
Provides oversight and reviews all outsourced activities (protocol to CSR) in Clinical Pharmacology (NHV) studies.
Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.
Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.
Ensures appropriate methods are used when communicating with key stakeholders and cross functional partners.
Creates realistic plans that clearly define goals, milestones, responsibilities, and results.
Maintains focus on strategic objectives while accomplishing operational goals.
Places a priority on getting results with an emphasis on high quality outcomes.
Holds self and others accountable for accomplishing goals.
Makes timely, data-driven decisions while balancing against daily priorities.
Develops and maintains effective working relationships with people across cultures.
Incorporates global considerations in everyday decision-making.
Encourages collaboration across teams, functions, and geographies.
Ensures that conflict is handled constructively so that performance is not impacted.
Displays a willingness to challenge the status quo and take risks.
Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.
Maintains optimism and composure in times of change, uncertainty, or stress.
Executes to deliver on corporate objectives.
Acts as a mentor for the Study Team and function.
Supports development of GDO best practices.
Actively manages team behavior by mediating internal disputes, promoting energy/commitment, and recognizing and rewarding accomplishments.
Seeks opportunities for continued learning as to how strategy is shaped in the organization.
BA/BS or equivalent degree in relevant discipline
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.
Risk management experience preferred.
Clinical trial project management skills.
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.
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.
Demonstrated project management and organizational skills with strong presentation and communication abilities.
Ability to manage multiple deliverables and nimbly respond to changing business demands.
Understands interdependencies, links possible solutions, and escalates issues with proposed solutions to appropriate people.
Reacts with a sense of urgency and responds appropriately.
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.
Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
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.
Has the 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).
Has the ability to review, interpret, and analyze information to support discussions and make decisions.
Ability to effectively lead a cross-functional team in a matrix environment.
Time management skills - ability to effectively multi-task and set priorities with minimal guidance.
Comes with ideas or perspectives when seeking guidance from Operations Portfolio Leads and/or other team members.
Fosters a continuous learning mindset.
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.
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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.
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