Join to apply for the Clinical Trial Manager role at Bristol Myers Squibb.Working with UsChallenging. 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.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 at careers.bms.com/working-with-us.Clinical Trial Manager (CTM) – based in Rome is accountable for end-to-end study operational oversight and delivery at country level (Italy, Greece, Israel and Croatia), ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.Key Responsibilities
Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.Plans, develops and executes timelines and activities for start-up in collaboration with the local study team and other relevant stakeholders.Implements country and site level patient recruitment strategy and risk mitigation, coordinating and ensuring country level study enrolment targets and timelines are met.Leads problem-solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder(s).Assesses and sets up vendors during study start-up period (locally).Participates in Investigator Meetings and prepares related materials.Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and that access to eDC and vendor systems is available for the country and clinical trial site personnel, including uploading documents in eTMF.Validates study-related materials (i.e. protocol, ICF, patient material).Reviews country and site-specific documents (e.g. ICF, patient material) and prepares site-level ICF and other documents where applicable.Supports preparation of materials for Site Initiation Visits.Verifies and confirms with local team eTMF completeness (Country and Site level). Prepares investigator sites to conduct clinical trials by verifying acceptability of Clinical Trial Package (CTP) documentation.Acknowledges Site Monitoring visit reports, takes action within specified timelines and escalates issues, ensuring appropriate documentation.Coordinates database locks and query follow-up, ensuring timelines are met.Ensures inspection readiness of assigned trials within country and provides support to Health Authority inspection and pre-inspection activities.Coordinates and completes Corrective Actions / Preventive Actions (CAPA), ensuring implementation for Country audit level findings and drives CAPA review, implementation and completion.Coordinates study team meetings locally.Supports stakeholder resolution of queries related to site invoices and coordinates patient compensation claims (if applicable).Collaborates with the local study team to support management of site relationships (may include CRO related issues).May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs); may perform site closure activities, including post-close-out; may act as point of contact for Sites.As required per country requirements, performs or supports preparation of submissions to Health Authorities, including follow-up until approval, covering substantial amendments and other HA submission documents.Performs submission to Ethics Committees and governance offices, where applicable, and coordinates MOH responses with regulatory and central teams.Supports collection and distribution of documents to and from sites; supports approval for closure of funds/POs; may update national registries where applicable.Serves as a coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal.
Qualifications & Experience
Bachelor's or master's degree in life sciences or equivalent field of study.Minimum of 4 years of industry-related experience.Experience leading or participating as an active member of cross-functional teams, task forces, or local and global initiatives.Acted as a key resource for colleagues by providing guidance, leading training and mentoring peers through informal or formal presentations.Served as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with opportunity to contribute regionally or globally.
Competencies
Deep understanding of GCP, ICH Guidelines and related local guidance, regulation and codes of practice.Knowledge of clinical research processes, regulations and methodology.Understanding of the clinical landscape with practical knowledge of various medical settings and medical records management.Demonstrated organizational and planning skills and independent decision-making ability.Strong organizational and time management skills, able to manage multiple competing priorities effectively.Interpersonal, oral and written communication skills to influence, inform, or guide others.Proficient verbal and written communication skills in English and the local language.
Software
Microsoft SuiteCTMSeDCeTMF
Travel Required occasionally.If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Additional InformationUniquely Interesting Work, Life-changing CareersWith a vision as inspiring as "Transforming patients' lives through scienceTM", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each colleague.On-site Protocol: BMS has an occupancy structure that determines where an employee is required to conduct work. This includes site-essential, site-by-design, field-based and remote-by-design jobs. Site-essential roles require 100% shifts onsite at the assigned facility. Site-by-design roles may qualify for a hybrid work model with at least 50% onsite. Field-based and remote-by-design roles may require traveling to visit customers, patients or business partners and attending meetings as directed.Supporting People With Disabilities: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support. Applicants can request a reasonable accommodation before accepting a job offer. If you require accommodations in completing this application, direct inquiries to ******. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Candidate Rights: BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Data Protection: We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at LevelMid-Senior levelEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical Manufacturing#J-*****-Ljbffr