Senior Clinical Research Associate

Benefits

Additional Information

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 . Position Summary: Senior Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements. Duties/Responsibilities: Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable. Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level. Motivate and influence sites to meet study objectives, including enrollment and retention goals. Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method 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. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process. 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, including implementing mitigation strategies based on risk indicators Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable. Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions. May support Ethics Committee submissions, ICF reviews, collection of documents to/from site Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities. Support coordination of site activities related to database locks to ensure timelines are met as required locally. 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, responsible for operational outcomes and deliverables. May engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues and widespread issues (i.e. country level issues). May serve as a role subject matter expert for continuous improvement initiat