Bristol-Myers Squibb is a global
Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.
Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Key Responsibilities and Major Duties
Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
Coordinates with other internal roles in 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.
List of minimum requirements
Degree / Certification / Licensure
Bachelors or Masters Degree within life sciences or equivalent
Experience Responsibility and minimum number of years
Clinical Trial Manager : Minimum of 4 years' industry related experience
Senior Clinical Trial Manager : 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
Competencies knowledge, skills, abilities, other
Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
In depth 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 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 local language).
Software that must be used independently and without assistance (e.g., Microsoft Suite)
Clinical Trial Management Systems (CTMS)
Electronic Data Capture Systems (eDC)
Electronic Trial Master File (eTMF)
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.
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Working with Us
By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases.
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