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.

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Position Summary

• Provides operational support for 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.

• Manages the development and/or collection of study level documentation and support Global Trial Lead (GTL) in ensuring eTMF accuracy and completion for all studies.

• Has high functional impact on the study team and the organization. Manages country planning, protocol level attributes and milestones/drivers in CTMS.

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

Duties/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 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

Reporting Relationship

This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

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.

Education/Experience

• BA/BS or equivalent degree in relevant discipline required

• Min. 4-6 years of clinical research/global study operations experience

• Moderate familiarity with global regulatory landscape/submission timelines

• No direct project management experience required

• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems

• Travel requirement of up to 5%

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

We kindly ask all applicants to send their CV in English. Multiple positions available.

#LI-Hybrid 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.

Compensation Overview: Warsaw - PL: zł239,890 - zł290,697

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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/

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R1600641 : Principal Global Trial Associate