Clinical Trial Manager
Bristol-Myers Squibb
Taipei,Taiwan
5天前

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)
  • 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.

    Explore Job Opportunities

    A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move.

    Come Meet Our Team

    Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more.

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