Role Description The 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. - 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. - 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. - 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. - 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. - Utilize strong analytical skills to evaluate site data and operational metrics. - Perform Unblinded Site Monitoring 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 start-up and submission related activities, including ICF reviews and 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. - Participates in site level root cause analysis and CAPA (Corrective and Preventive Actions) processes. Qualifications - Bachelor’s degree required, preferably within life sciences or equivalent. - Valid driver’s license (as locally required). Requirements - 2-3 years of relevant clinical research experience as a Clinical Research Associate. - 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. - Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations. - Strong analytical and critical thinking skills. - Good verbal and written communication skills (both in English and local language). - Ability to manage multiple protocols across multiple therapeutic areas. - Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards). Benefits - Wide variety of competitive benefits, services and programs. - Resources to pursue goals, both at work and in personal lives.