Clinical Trial Manager

Working with Us Challenging.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.Take your career farther than you thought possible.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: careers.bms.com/working-with-us.The 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 ResponsibilitiesActs 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.Implement country and site level patient recruitment strategy and risk mitigation.Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder(s).Assessment and set up of vendors during study start-up period (locally).Investigator Meeting participation and preparation.Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel.Includes entering necessary data and uploading documents in eTMF.Validation of study related materials (i.e. protocol, ICF, patient material).Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.May support preparation of materials for Site Initiation Visits.Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.Acknowledges 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 and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings.Drives CAPA review, implementation and completion.Coordinate study team meetings locally.Supports the stakeholder in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable).Collaborates with the local study team to support the 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, perform or support the preparation of submissions to Health Authorities including follow-up until approval.This includes substantial amendments and any other documentation requiring HA submission.Perform submission to Ethics Committees and governance offices, where applicable, including follow-up until approval (protocol, amendments/IB and any other documents requiring EC submission).Coordinate the MOH responses with regulatory and central teams, as applicable.May support the collection and distribution of documents to and from sites.Support the 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 & ExperienceBachelor's or master's degree required.Field of study within life sciences or equivalent.Minimum of 4 years' industry related experience.Experience in leading or participating as an active member of cross-functional teams, task forces, or local and global initiative.Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using informal and/or formal presentations.Serve as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with the opportunity to contribute at a regional or global level with this expertise.CompetenciesDeep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.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.Strong organizational and time management skills and ability to effectively manage multiple competing priorities.Interpersonal, oral and written communication skills to influence, inform or guide others.Good verbal and written communication skills (both in English and local language).SoftwareMicrosoft SuiteCTMSeDCeTMFTravel Required occasionally#LI-HYBRIDIf 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.Uniquely Interesting Work, Life-Changing CareersWith a single vision as inspiring as "Transforming patients' lives through scienceTM" each 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 of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work.This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.The occupancy type that you are assigned is determined by the nature and responsibilities of your role.Site-essential roles require 100% of shifts onsite at your assigned facility.Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.Supporting People with DisabilitiesBMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process.Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.#J-*****-Ljbffr