Sr. Global Trial Associate

Working with UsChallenging. 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.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  Manages the development and/or collection of study level documentation & support Global Trial Lead (GTL) in ensuring eTMF accuracy & completion of for all studiesProvides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies.Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution. Proactively Identifies risks and develops/implements action to avoid or mitigate.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 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.Independently performs core Global Trial Associate (GTA) tasks and escalates/pushes back/delegates appropriately.Actively contributes to study meetings by leading assigned topics/components.Assist the Global Trial Lead (GTL) in driving study executionContributes to oversight of the required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC approvals/notifications.Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.Understands strategy and decision making at program level and their impact on the studies.Ability to contribute to initiatives for process development and improvement.Ability to assess a situation and identify path forward with the appropriate resources.Understands interdependence of tasks assigned.Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.Supports study specific CSR appendices, as needed. Manages vendors and site payment processing and tracking.Lead assigned study closure/archival activities during study closure phaseReporting RelationshipThis 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 and directives, and the drug development process.Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.Working knowledge of project management preferred.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. Acts as a role model in supporting change within the organization and has knowledge of cross-functional partners who can help clarify change. Mentors and coaches other team members and GTA’s, as appropriate, and participate or provide leadership in departmental initiatives.Builds relationships to achieve influence with others.Develops and maintains collaborative relationships with internal and external stakeholders to be more effective in the role.Displays a willingness to challenge the status quo and take risks.Effective oral/written communication and presentation skills, ability to collaborate with key stakeholders and across the organization.Education/Experience/ Licenses/Certifications: BA/BS in relevant discipline strongly preferred.Minimum 2-4 years’ experience in Clinical Research or related work experience. Global experience is preferred.Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.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.Uniquely Interesting Work, Life-changing CareersWith 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 ProtocolBMS 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 th