Global Trial Manager
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.
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.
- 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.
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.