Clinical Trial Monitor

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Key Responsibilities: Monitors study sites following the monitoring plan, BMS SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory. Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP Guidelines and local regulations. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements. Reviews site activities and quality through on-site visits in addition to remote management capabilities. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities. Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrollment and retention goals. Resolves study site problems/issues as they occur. More complex issues may be resolved jointly with management. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective actions are implemented. Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites. Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators. Recommends sites for consideration in future studies, as needed Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers. Facilitates the Regulatory Compliance audit process, as needed. Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner. Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues, etc.). Uses multiple technologies to maintain open and frequent communication with all stakeholders. Exhibits flexibility and adaptability when facing change. Employs good fiscal management for travel expenses, etc. Ability to perform site management activities, as required. Performs other tasks, as assigned or requested by line manager Qualifications: Bachelors degree in the Field of study within life sciences or equivalent 2-3 years of relevant clinical research experience, able to work independently. Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred Experience in the drug discovery/development process. Basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials. Knowledge and understanding of clinical research processes, regulations and methodology Understanding of clinical landscape with practical knowledge of a variety of medical settings and medical records management Organization and time management skills. Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations Good verbal and written communication skills (both in English and local language). No restriction for travelling Based in Istanbul or willing to move Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.