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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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PHASE IV Associate Global Trial Manager
Division-Research and Development
Functional Area Description
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. Position Summary / Objective
• Provides operational support on global insourced or outsourced, Non-Registrational Data Generating or 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.
• Experience with CTMS systems is a plus.
Key Competency Requirements
Technical Competencies
• Knowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes.
• Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint.
Management Competencies
• Demonstrated project management experience in the pharmaceutical or healthcare industry.
• Ability to manage multiple deliverables and nimbly respond to changing business demands
• 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.
• Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams
• Has adequate knowledge of the projects (both insourced and outsourced), and the ability to zoom in and out as the situation demands.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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