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 Role**
We are now looking for an **Clinical Trial Manager,** who will be responsible for study oversight and delivery management (time, budget, quality) from start-up to closure for 3 countries (Italy, Greece and Israel).
Serves as the main point of contact at a country level for internal and external stakeholders




The position is based in Rome - Italy
**Key Duties And Responsibilities**
- Coordinates country cross functional teams and acts as the main point of contact for the 3 countries with the protocol manager and other global study team members
- Coordinates with other internal roles in the country and site feasibility process, 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
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
- Assessment and set up the of vendors during study start up period (locally)
- 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 the Country 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
- Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
- Management of 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.
**Qualifications, Knowledge and Skills Required**
- Bachelors or Masters Degree within pharmacology or life sciences field or equivalent
- Minimum 4 years’ industry related experience
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of Clinical Research - Clinical Trials 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 organization and time management skills and ability to effectively manage multiple competing priorities
- Ability of critical thinking and risk analysis.
- Strong communication skills with a strong 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 Italian language).
Software that must be used independently and without assistance
- Microsoft Suite
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture Systems (eDC)
- Electronic Trial Master File (eTMF)
- L’appartenenza alle categorie protette, lg. 68/99 costituirà titolo preferenziale_._
**What’s important to us**
Employees are expected to display the BMS Values, which move us toward our mission to discover,



develop and deliver innovative medicines that help patients prevail over serious diseases:
**Passion**_: Our dedication to learning and excellence helps us to deliver exceptional results. _
**Innovation**: _We pursue disruptive