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    Senior Clinical Trial Manager - Roma, Italia - Bristol-Myers Squibb

    Bristol-Myers Squibb
    Bristol-Myers Squibb Roma, Italia

    4 settimane fa

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    Descrizione
    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 rich in diversity.

    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:
    .
    The Role

    We are now recruiting a Senior Clinical Trial Manager – Office Based in ROME , 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 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.

    Senior Level Expectations:

    Engage with Global Trial Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally

    Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations

    May be assigned as a Lead CTM for a study locally and as determined by leadership

    Qualifications, Knowledge and Skills Required
    Bachelors or Masters Degree within pharmacology or life sciences field or equivalent

    At least 6 years of 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 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.

    #LI-ONSITE

    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.
    Uniquely Interesting Work, Life-changing Careers

    With a single vision as inspiring as "Transforming patients' lives through science ", 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 an inclusive culture, promoting diversity 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 Protocol
    BMS has a diverse 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.

    BMS 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 eeo -accessibility to access our complete Equal Employment Opportunity statement.
    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

    As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

    #J-18808-Ljbffr
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