Clinical Trial Manager

hace 2 semanas

Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo

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.

Key Responsibilities and Major Duties

  • Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocolmanager and other global study team members
  • Coordinates with other internal roles in country and site feasibility process, including proposal and validation ofcountry study targets
  • Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level studyenrolment targets and timelines are met
  • Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution andescalation 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 vendorsystems 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 ensuresappropriate 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 preinspection activities
  • Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation forCountry 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 postclose 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.

Requirements:

  • Bachelor's degree required preferably within life sciences or equivalent.
  • Minimum of 4 years' industry related experience
  • 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 decisionmaking 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).
  • Knowledge in Software:
  • Microsoft Suite
  • Clinical Trial Management Systems(CTMS)
  • Electronic Data Capture Systems (eDC)
  • Electronic Trial Master File (eTMF)
LI-hybrid

Uniquely Interesting Work, Life-changing Careers

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

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