Bristol Myers Squibb
PrincipalGlobalTrialAssociate
“Principal Global Trial Associate at Bristol Myers Squibb. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics. Provides operational support for global clinical trials. May be responsible for clinical trial maintenance or close-out”
What You'll Achieve.
Transforming patients’ lives through science™
Industry & Context.
Solves routine problems/issues; Escalates to GTL or other related functions as needed; Exposure to situations where benefit-risk and issues assessments need to be managed
Travel requirement of up to 5%, option to work remotely up to 50% of the time
What They're Looking For.
Must Have
BAS 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, Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems
Nice to Have
No direct project management experience required
What You'll Do.
Provides operational support for global clinical trials
May be responsible for clinical trial maintenance or close-out
Provides operational support to cross-functional study teams
Provides oversight of Contract Research Organization (CRO) teams
Manages development/collection of study documentation
Supports Global Trial Lead (GTL) in ensuring eTMF accuracy
Manages country planning
Supports study execution utilizing performance metrics
Oversees clinical monitoring quality and adherence
Supports/manages discrete study deliverables
Proactively identifies potential risks
Solves routine problems/issues
Informs GTL and leadership on clinical trial plans
Supports creation and implementation of project management tools
Manages study level documentation and eTMF quality
Supports GTL's review of study documents
Supports country and site feasibility/selection
Supports development of subject recruitment/retention strategy
Oversees/Supports study specific CSR appendices
Supports GTL in communicating with IRB/IEC
protocol deviation review
Participates in Audit Response Team
Manages company-sponsored study types
Reviews vendor invoices and leads approval process
Manages accruals and LSD/SOW changes
Provides input to vendor scope of work/LSD
Reviews study budget worksheet for completeness
Participates in updating financial forecasting
Supports GTL with financial reconciliation activity
Manages/oversees vendors
Participates in study team meetings
Supports or leads study closure activities
How You'll Work.
Team & Collaboration
Facilitate collaboration across teams; Develops and maintains effective working relationships with people across functions; Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams; Collaborate with cross-functional global teams
Communication Scope
Leverages interpersonal and influencing skills
Process & Methodology
project management concepts, management of issues, risks, timelines, and budget, Supports study execution utilizing performance metrics, Supports/manages discrete study deliverables, Proactively identifies potential risks, Solves routine problems/issues, Supports creation and implementation of project management tools, Demonstrated project management experience
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