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Clinical Trial Manager

hace 3 meses

Madrid, Madrid, España 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.

Purpose of the job
Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders

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 member.
  • 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 preinspection 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 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.

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.

Requirements:

  • Bachelor's degree required preferably within life sciences or equivalent.

  • 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.

Bristol-Myers Squibb is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to gender identity, race, color, religion, sexual orientation, national origin or disability.


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 ar