Principal Global Trial Associate

Working with Us
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. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

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 Responsibilities

• Supports study execution utilizing available performance metrics and quality indicators
• May oversee clinical monitoring quality and adherence to established processes and plans
• Supports/manages discrete study deliverables (i.e., timelines, study plans, CTMS, etc.) through collaboration with internal and external stakeholders to inform robust data driven decisions
• Proactively identifies potential risks, support Global Trial Lead (GTL) leading study in development/implementation of actions, and contributes to discussions on appropriate trade-offs of balancing risks with study deliverables and costs.  In situations where Principal GTA is the lead of a study, they will manage development and implementation of actions associated with identified risks.
• Solves routine problems/issues; escalates to GTL or other related functions as needed
• Informs lead GTL and other leadership (as appropriate) on overall clinical trial plans and of potential issues/mitigation
• Exposure to situations where benefit-risk and issues assessments need to be managed
• Supports creation and implementation of project management tools at study level (issues log and risk management plan – drives tool maintenance

Study Planning, Conduct & Closure Responsibilities

• Manages the development/set-up and/or collection of study level documentation and support GTL in ensuring eTMF accuracy, completion and ongoing quality for all studies.
• Supports GTL's review of study documents such as synopsis, protocol/protocol concept sheet, ICF, CRFs, CRF completion Guidelines, Study Execution plans, Clinical Data Review Plan, Clinical Database edit specification, Clinical Study Report (CSR).  In situations where Principal GTA is the lead of a study the will perform these tasks.
• 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
• Oversee/Supports study specific CSR appendices, as needed.
• Supports GTL in providing input and communicating with the appropriate teams for response to country/regulatory 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 vendor invoices and lead approval process or submits to GTL's for approval (as needed); manages accruals and LSD/SOW changes.
• Provides input to the development/management of the vendor scope of work/LSD per contract, quality, and budget under the supervision of the GTL and outsourcing manager
• Reviews the study budget worksheet for completeness and accuracy
• Participates in updating financial forecasting and support GTL with financial reconciliation activity
• May support GTL in managing/overseeing vendors
• Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
• May support or lead study closure activities

Leadership Competencies

• Can operate in a highly independent fashion; proactive in trying to find solutions before flagging to direct reports
• Helps GTL facilitate collaboration across teams, functions; looks for opportunities to lead meetings/discussions
• Accomplishes operational tasks with overall project objectives in mind; shows foresight in flagging to GTL
• Acts as a mentor for more junior Global Trial Associates (GTAs)
• Flexible and can adapt to different GTL working styles
• Develops and maintains effective working relationships with people across functions, therapeutic areas (TAs), cultures
• Maintains optimism and composure in times of change, uncertainty, or stress and shows willingness to take on added responsibility during peak periods
• Provides input into timely, data-driven decisions
• Looks to build understanding of global considerations by participating in RDL-GTL and CTM-GTL discussions
• Seeks opportunities to participate in strategy discussions; looks to get exposure to studies across phases, TAs, locations
• Motivates team members
• Has a high impact on study team and enables GTL

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604570 : Principal Global Trial Associate