Associate Global Trial Manager Early Development and Cell Therapy

Job content

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and with 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 Clinical Trial Strategy and Operations sits within Global Development Operations. Conducting clinical trials is one of the company’s most critical pursuits to develop and bring new medicines to patients in need. Global Development Operations plans, manages and executes BMS clinical trials across approximately 40 countries.

The Associate Global Trial Manager Early Development and Cell Therapy provides operational support on global insourced or outsourced, Registrational Data Generating interventional clinical trials from concept to final clinical study report.

• May be responsible for a clinical trial(s) in the maintenance or close-out phases of its life cycle.
• May provide operational support to 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.
• Focuses on project management concepts to support management of issues, risks, timelines and budget.
  

Disclaimer The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned. Position Responsibilities

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

Project Management

• Supports study execution utilizing available performance metrics and quality indicators.
• Oversees clinical monitoring quality and adherence to established processes and plans.
• Supports / manages study deliverables (i.e. timelines, study plans, CTMS etc.) through collaboration with internal and external stakeholders to make robust data driven decisions.
• Proactively identifies potential risks and supports the development and implementation of actions to avoid or mitigate and is able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
• Solves routine problems and issues and escalates issues to appropriate people.
• Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and of potential issues/mitigation.
• Exposure to situations where benefit-risk and issue assessments need to be managed.
• 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

• Oversees TMF set-up, ongoing quality review, and final reconciliation of study documents.
• Provides operational review and input into study documents such as synopsis, protocol/Protocol Concept Sheet, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR), etc.
• May develop/coordinate targeted study training for study team, investigational sites, and vendors.
• Supports country and site feasibility/selection processes with use of robust data.
• May support the development of the subject recruitment/retention strategy and related initiatives.
• Oversees study specific CSR appendices.
• Supports the GTM in providing input and communicating with the appropriate teams for response to country/regulatory and IRB/IEC.
• Assists with data, protocol deviation review, and study level trackers.
• Participates in Audit Response Team, CAPA, and Inspections.
• May be responsible for managing certain company-sponsored study types from start-up through close-out (e.g. NPP, HEOR with patients).
• Reviews and approves vendor invoices and manages accruals and LSD / SOW changes.
• Provides input to the development/management of the vendor scope of work (SOW) / LSD per contract, quality, and budget under the supervision of the GTM and outsourcing Manager.
• Reviews the study budget worksheet for completeness and accuracy.
• Participates in updating financial forecasting.
  

Leadership Competencies

• Encourages collaboration across teams, functions, and geographies.
• Maintains focus on project objectives while accomplishing operational goals.
• Provides guidance to Global Trial Specialists (GTS).
• Adheres to the strategy and vision of the Global Trial Management function.
• Develops and maintains effective working relationships with people across cultures.
• Maintains optimism and composure in times of change, uncertainty, or stress and motivates team members.
• Provides input into realistic plans that clearly define goals, milestones, responsibilities, and results.
• Provides input into timely, data-driven decisions.
• Has exposure to global considerations.
• Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.
• Motivates team members.
• Has a high impact on the study team and a moderate impact on the function. Degree Requirements
  

BA/BS Or Equivalent Degree In Relevant Discipline Experience Requirements

• Minimum 2 years of clinical study management or equivalent experience.
• Demonstrated project management experience in the pharmaceutical or healthcare industry.
  

Physical presence requirement

This role requires 50% physical presence as this is an essential job function of this role.

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.