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; Maintain data integrity; Maintain data reliability; Ensure patient safety; Meet timelines locally
Industry & Context.
Risk assessment; Risk mitigation; Data evaluation; Troubleshooting
Site-essential roles, Site-by-design roles, Field-based roles, Remote-by-design roles, Travel to visit customers, Travel to visit patients, Travel to visit business partners, Attend meetings on behalf of BMS
What They're Looking For.
Must Have
Act as point of contact for Sites, Implement local country and site feasibility process, Plan, develop and execute timelines and activities for start-up, Support local regulatory in preparing and performing submissions, Manage end-to-end process for executing Clinical Trial Agreements, Prepare contract documents from templates, Negotiate financial and legal aspects of CTAg, Prepare country Informed Consent Form, Review and approval of Clinical Trial Package documentation, Ensure eTMF contains relevant Clinical Trial Package regulatory documents, Update national registries as applicable, Prepare 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 documents to and from sites, Maintain ethical and scientific integrity of clinical trials, Verify data within electronic systems and paper records, Monitor site adherence to ICH GCP and local regulations, Comply with principles of ALCOA, 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 needs of different stakeholders, Prepare and submit written reports, Assess potential Investigators and their 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 and operational metrics, Perform Unblinded Site Monitor activities, Accountable for review, reconciliation, and oversight of study drug/IMP, 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 for
Support local regulatory in preparing and performing submissions
Manage end-to-end process for executing Clinical Trial Agreements
Prepare contract documents from templates
Modify contract documents to reflect unique aspects
Negotiate financial and legal aspects of CTAg
Negotiate Master Service Agreements
Prepare country Informed Consent Form
Manage country ICF template
Review and approval of Site ICFs
Review and approval of Clinical Trial Package documentation
Ensure eTMF contains relevant Clinical Trial Package regulatory
Update national registries as applicable
Prepare materials for Site Initiation Visits
Conduct support Investigator Site Assessment Visits
Conduct Site Initiation Visits
Conduct site qualification visits
Conduct site initiation visits
Conduct routine monitoring visits
Conduct site close-out visits
Perform post-close out visits
Ensure adherence to protocol
Ensure adherence to BMS Standard Operating Procedures
Ensure adherence to ICH GCP
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 of clinical trials
Maintain scientific integrity of clinical trials
Verify data within electronic systems
Verify data within paper records
Ensure accessibility of data
Ensure completeness of data
Ensure accuracy of data
Monitor site adherence to ICH GCP
Monitor site adherence to local regulations
Uphold standards to maintain data integrity
Uphold standards to maintain data reliability
Ensure patient safety
Cultivate effective relationships with internal teams
Cultivate effective relationships with external partners
Sustain effective relationships with vendors
Sustain effective relationships with clinical sites
Sustain effective relationships with key stakeholders
Motivate sites to meet study objectives
Influence sites to meet study objectives
Motivate sites to meet enrolment goals
Influence sites to meet enrolment goals
Motivate sites to meet retention goals
Influence sites to meet retention goals
Communicate effectively
Adapt communication to meet stakeholder needs
Utilize appropriate communication style
Utilize appropriate communication method
Prepare written monitoring reports
Prepare administrative reports
Submit written reports
Assess potential Investigators
Assess Investigator sites
Identify new potential Investigators
Identify new potential sites
Demonstrate understanding of targeted monitoring approaches
Demonstrate understanding of centralized monitoring approaches
Demonstrate understanding of remote monitoring approaches
Demonstrate understanding of risk-based 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 based on risk indicators
Utilize analytical skills to evaluate site data
Utilize analytical skills to evaluate operational metrics
Adjust monitoring strategies based on data trends
Adjust monitoring strategies based on site performance
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 needs
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 kept up to
Support coordination of site activities related to database
Ensure timelines are met locally
Perform timely site closure
How You'll Work.
Team & Collaboration
Local study team; Global Trial Acceleration Centre; Internal cross-functional teams; External partners; Clinical sites; Key stakeholders
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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