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.

Position Summary

• Contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
• Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
• Primarily works on routine to complex projects/trials at varying stages.
• Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance. Manages country planning, protocol level attributes and milestones/drivers in CTMS.
• 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.
• Support Global Trial Lead (GTL) in tracking of non-clinical supplies
• Support Global Trial Lead (GTL) in vendor management related activities

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

• Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.

• Resolves routine problems and escalates important issues appropriately (with a sense of urgency).

• Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning, Conduct and Management

• Understands study level tools and plans.

• Simple studies or studies in closure phase may be managed in alignment with OPL or GTL.

• Reviews vendor invoices and lead approval process or submits to GTL's for approval (as needed); manages accruals and LSD/SOW changes

• Manages the development and/or collection of study level documentation and supports GTL in ensuring eTMF accuracy and completion for all studies.

• Provides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities. Study SharePoint/study directory updates and the Global Vendor Site List etc.

• Provides operational input and participates in operational processes in support of startup maintenance and close out of studies.

• Assist the GTL in driving study execution.

• Learns, observes and performs core GTA tasks and escalates appropriately.

• Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.

• Raises possible issues for potential escalation to the appropriate colleagues.

• Follows instructions, determines level of understanding and seeks clarification when needed.

• Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.

• Supports study specific CSR appendices, as needed.

• Manages global vendor site lists and resolve issues related to global site lists.

• Manages study mail-groups/distributions and SharePoint/Study Directory updates.

• Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.

• Identifies issues and risks, develops mitigations, and escalates appropriately.

• Participates in filing activities and any associated audits as applicable.

• Lead assigned study closure/archival activities during study closure phase

• 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.

Qualifications Specific Knowledge, Skills, Abilities:

Technical Competencies

• Basic knowledge of clinical research budgets including processing, reporting and tracking of vendor payments is a plus.

• Knowledge of ICH/GCP and regulatory guidelines/directives.

• Basic understanding of project management is desired.

Management Competencies

• Begin to network and foster relationships with key stakeholders across the study team.

• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

• Displays a willingness to challenge the status quo and take risks.

• Effective oral/written communication skills, ability to collaborate with key stakeholders and across the organization.

Education/Experience/ Licenses/Certifications:

• BA/BS or associate degrees in relevant discipline is strongly preferred

• 2-4 yrs of experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is preferred.

• Experience in Clinical Research or related work is a plus.

• Global experience is a plus.

• Travel required less than 5%.

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.

Warsaw - PL: zł223,020 - zł270,251

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/

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.

R1600588 : Global Trial Associate