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. Supporting People with Disabilities 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 initiatives and process enhancements as needed 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 (Corrective and Preventive Actions) processes Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations May be delegated by line management to conduct monitoring onboarding and ongoing competency assessments Junior Clinical Research Associate: At least 1 year of relevant clinical research experience, able to work independently but may not have experience in all aspects of the role Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role Senior Clinical Research Associate: 5 years of monitoring experience. Demonstrates leadership attributes and capability to take on mentor/coach role. Extensive experience and demonstrated strong performance in all aspects of the role. (Note, 5 years of monitoring experience preferred but a combination of monitoring and relevant clinical research experience can be considered). Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred Experience in the drug discovery/development process. Knowledge and understanding of clinical research processes, regulations and methodology Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities (Analytical thinking/critical thinking skills. Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions). Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment Organization and time management skills Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders Good verbal and written communication skills (both in English and local language) Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc.) Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity Bachelor's degree required, preferably within life sciences or equivalent Valid driver's license (as locally required)