Bristol Myers Squibb Hiring For Senior Clinical Research Associate

Responsibilities

• Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases
• Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records
• Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA
• Cultivate and sustain effective relationships with internal cross-functional teams and external partners
• Motivate and influence sites to meet study objectives, including enrollment and retention goals
• Communicate effectively, adapting to meet the needs of different stakeholders
• Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
• Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials
• Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
• Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues
• Utilize strong analytical skills to evaluate site data and operational metrics
• Perform Unblinded Site Monitor activities to protect the blind of the study
• Accountable for the review, reconciliation, and oversight of study drug/IMP
• Involvement in Regulatory Compliance audit/inspection process, as needed
• Support Ethics Committee submissions, ICF reviews, collection of documents to/from site
• Support provision of access to relevant BMS and vendor systems for clinical trial site personnel
• Support coordination of site activities related to database locks to ensure timelines are met
• Perform timely site closure activities when all required protocol visits and follow-up are completed
• Functions independently and acts autonomously
• May serve as Lead CRA for a local study as directed by RCO Country/Cluster leadership
• May engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues
• May serve as a subject matter expert for continuous improvement initiatives and process enhancements
• Serve as a subject matter expert in risk-based management methodologies and tools
• Serve as a subject matter expert in root cause analysis and CAPA processes
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members
• May be delegated by line management to conduct monitoring onboarding and ongoing competency assessments

Skills

• Knowledge of clinical research processes, regulations and methodology
• Understanding of ICH/GCP Guidelines and applicable local laws and regulations
• Analytical thinking and critical thinking skills
• Ability to use technology to analyze diverse and complex data sets
• Organization and time management skills
• Ability to build, maintain and strengthen relationships with internal and external stakeholders
• Good verbal and written communication skills
• Foundational level of disease understanding and awareness
• Ability to work independently with a high degree of autonomy
• Proficient in navigating and utilizing multiple clinical systems
• Microsoft Suite
• Clinical Trial Management Systems (CTMS)
• Electronic Data Capture Systems (eDC)
• Electronic Trial Master File (eTMF)
• RBM tools and platforms

Company Overview

Bristol Myers Squibb is a leading global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. With a strong presence in the pharmaceutical industry, the company is committed to transforming patients’ lives through science. Bristol Myers Squibb offers a wide range of competitive benefits, services and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives. The company values passion, innovation, urgency, accountability, inclusion and integrity, and is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

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