Bristol Myers Squibb
Healthcare
CRAII
Neural analysis suggests this role is
optimal for Mid+ candidates.
“CRA II at Bristol Myers Squibb. Skills: Clinical trial management, Site monitoring, Regulatory compliance. Act as point of contact for Sites. Implement local country and site feasibility process”
What You'll Achieve.
Meet study objectives; Meet enrolment goals; Meet retention goals
Industry & Context.
Risk mitigation; Data analysis; Troubleshooting
What They're Looking For.
Must Have
Act as point of contact for Sites, Implements local country and site feasibility process, Plans, develops and executes timelines and activities for start-up, Support local regulatory in preparing and performing submissions, Manage end-to-end process for executing Clinical Trial Agreements, Prepares contract documents from templates, Negotiates financial and legal aspects of CTAg, Prepare country Informed Consent Form, Review and approval of Clinical Trial Package documentation, Ensures eTMF contains relevant Clinical Trial Package regulatory documents, Update national registries as applicable, Prepare of materials for Site Initiation Visits, Conduct support Investigator Site Assessment Visits, Conduct Site Initiation Visits, Conduct site qualification, initiation, routine monitoring and close-out visits, Perform submission to Site Ethics Committees, Coordinate Site Ethics Committees and Site GCP Institution responses, Collect and distribute of documents to and from sites, Maintain ethical and scientific integrity of clinical trials, Monitor site adherence to ICH GCP and local regulations, Provide training and support to site staff, Cultivate and sustain effective relationships, Serve as organization’s representative for clinical trials, Motivate and influence sites to meet study objectives, Communicate effectively, adapting to meet needs, Prepare and submit written reports, Assess potential Investigators and their sites, Identify new potential Investigators and/or sites, Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches, Identify, assess, and prioritize risks at site and study level, Support sites in mitigating issues, Utilize analytical skills to evaluate site data, Adjust monitoring strategies based on data trends, Perform Unblinded Site Monitor activities, Accountable for review, reconciliation, and oversight of study drug/IMP, Support study drug/IMP label translation needs, Involvement in Regulatory Compliance audit/inspection process, Develop and implement site corrective and preventive actions, Support provision of access to relevant BMS and vendor systems, Ensure internal BMS systems are kept up to date, Support coordination of site activities related to database locks, Perform timely site closure
What You'll Do.
Act as point of contact for Sites
Implement local country and site feasibility process
develop and execute timelines and activities
Support local regulatory in preparing submissions
Manage end-to-end process for executing CTAgs
Prepare contract documents from templates
Modify contract documents
Negotiate financial and legal aspects of CTAg
Negotiate Master Service Agreements
Prepare country Informed Consent Form
Manage country ICF template
Review and approve Site ICFs
Review and approve Clinical Trial Package documentation
Ensure eTMF contains relevant CTP regulatory documents
Update national registries
Prepare materials for Site Initiation Visits
Conduct Investigator Site Assessment Visits
Conduct Site Initiation Visits
Conduct site qualification visits
Conduct site initiation visits
Conduct routine monitoring visits
Conduct close-out visits
Perform submission to Site Ethics Committees
Perform submission to Site GCP Institution
Follow up until approval
Coordinate Site Ethics Committees responses
Coordinate Site GCP Institution responses
Collect documents from sites
Distribute documents to sites
Obtain insurance certificates
Maintain ethical integrity
Maintain scientific integrity
Verify data within electronic systems
Verify data within paper records
Ensure data accessibility
Ensure data completeness
Monitor site adherence to ICH GCP
Monitor site adherence to local regulations
Uphold ALCOA principles
Maintain data integrity
Maintain data reliability
Provide training to site staff
Ensure patient safety
Cultivate effective relationships
Sustain effective relationships
Serve as organization’s representative
Meet study objectives
Communicate effectively
Adapt communication to stakeholder needs
Utilize appropriate communication style
Utilize appropriate communication method
Prepare written reports
Submit written reports
Assess potential Investigators
Assess Investigator sites
Ensure sufficient resources
Ensure sufficient capabilities
Identify new potential Investigators
Identify new potential sites
Demonstrate understanding of monitoring approaches
Demonstrate proficiency in monitoring approaches
Identify risks at site level
Identify risks at study level
Assess risks at site level
Assess risks at study level
Prioritize risks at site level
Prioritize risks at study level
Support sites in mitigating issues
Implement mitigation strategies
Utilize analytical skills
Evaluate operational metrics
Adjust monitoring strategies
Perform Unblinded Site Monitor activities
Act as secondary monitoring source
Review study drug/IMP
Reconcile study drug/IMP
Oversee study drug/IMP
Support study drug/IMP label translation
Involve in Regulatory Compliance audit process
Involve in Regulatory Compliance inspection process
Develop corrective actions
Implement corrective actions
Develop preventive actions
Implement preventive actions
Support provision of access to BMS systems
Support provision of access to vendor systems
Ensure internal BMS systems are up to date
Support coordination of site activities
Ensure timelines are met locally
Perform timely site closure
How You'll Work.
Team & Collaboration
Internal cross-functional teams; External partners; Vendors; Clinical sites; Key stakeholders; Study teams
Communication Scope
Written reports; Monitoring reports; Administrative reports
Process & Methodology
Timeline management, Activity planning
Full Job Description
**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](https://careers.bms.com/working-with-us). * Act as point of contact for Sites. * Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership. * Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders through the review and approval of essential clinical trial and regulatory documents. * Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission. * Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites. * Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including the CTAg financial appendix * Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or ve
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