One shared journey is moving us forward at Bristol Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
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)
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 and bold solutions for patients.
Urgency: We move together with speed and quality because patients are waiting.
Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.
We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve