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

Descrizione

Senior Clinical Trial Manager page is loaded Senior Clinical Trial Manager Apply locations Rome - IT time type Full time posted on Posted 9 Days Ago job requisition id R 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.

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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
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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.

W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
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