Principal Global Trial Associate

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.

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.

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:

• 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.
• Assi…