Clinical Trial Manager

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. The Clinical Trials Manager role is responsible for the successful delivery of clinical trials run in the UK, Belgium, The Netherlands and Ireland. The role covers the operational management of the study locally, ensuring adherence to internal and external study requirements. Key point of contact for study communication with clinical trial sites, Clinical Trial Monitors, Clinical Trial Associates, Global Project Manager, Regulatory and Medical departments. Responsibilities: Coordinates cross country, functional teams and acts as the main point of contact with the Central study team Collaborates with internal stakeholders to perform country feasibility, site feasibility and site selection, including proposal and validation of country study targets Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met Guides problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholders Local vendor assessment and set up during study start-up (as applicable) Investigator Meeting participation and preparation Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for internal and clinical trial site personnel Validation of study related materials (i.e. protocol, ICF, patient material) Responsible for preparing country specific documents (e.g. global country specific amendment) Prepares materials for Site Initiation Visits Responsible for verifying and confirming with local team eTMF completeness (Country and Site level) Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. Coordination of database locks and query follow up. Ensures timelines are met. Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. Lead study team meetings locally Review and approve payments and manage patient compensation claims (if applicable) Management of clinical trial site relationships (includes CRO related issues) May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs) May perform site closure activities, including post-close out May act as point of contact for Sites May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances. Successful candidate will have: Thorough understanding of GCP, ICH Guidelines and Country regulatory environment In depth 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 Demonstrated organizational and planning skills and independent decision-making ability Good organization and time management skills and ability to effectively manage multiple competing priorities Ability of critical thinking and risk analysis. Excellent communication skills ensuring a customer focus, able to manage both internal and external clients at all organizational levels Skilled in the use of technology Good verbal and written communication skills (both in English and local language). Good working knowledge of following Software: Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC), Electronic Trial Master File (eTMF) Degree Requirements Bachelors or Masters degree required. Field of study within life sciences or equivalent Experience Requirements: Clinical Trial Manager: 3+ years' industry related experience Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
LI-Hybrid 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 recognises 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. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. If you require reasonable adjustments in completing this application, or any part of the recruitment process direct your enquiries to [email protected]. Applicants can request an approval of an adjustment prior to accepting a job offer.