Senior Clinical Research Manager

hace 4 semanas


Bogotá, Bogotá D.E., Colombia BOG Fortrea Colombia Ltda. A tiempo completo

Job Summary

BOG Fortrea Colombia Ltda. is seeking a highly skilled Sr. Payment Manager to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Key Responsibilities

  • Supervise assigned direct reports within the department.
  • Conduct detailed performance reviews and manage direct reports, including annual performance management and development, individual development plans, line of sight goals, and shoves and tugs.
  • Manage performance issues and their resolutions.
  • Measure performance indicators for assigned staff.
  • Educate and assist in the conduct of training and development efforts.
  • Conduct, report, and follow up on quality-related issues for direct reports as required.
  • Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams.
  • Develop and maintain effective relationships with management teams to manage assigned staff in a matrix environment.
  • Maintain good working relationships with all relevant stakeholders to ensure opportunities for acquiring additional business.

GCP and Quality Oversight

  • Ensure GCP training is completed, understood, and implemented for direct reports.
  • Identify GCP and quality issues through regular interactions with direct reports and plan and execute required actions to resolve those issues.
  • Ensure training compliance with training matrices and records are up to date.
  • Provide inputs on relevant SOPs and standard plans/templates for use by project management and clinical operations staff.

Additional Responsibilities

  • Assist in the onboarding of new direct reports, including conducting and delivering required job role-specific training.
  • Hold direct reports accountable for GCP issue escalations to the management team, the sponsor, or QA as applicable.
  • Hold staff accountable for quality and compliance with client SOP, Covance SOP, and deliverable timelines.
  • Coach staff on maintaining effective relationships with all relevant stakeholders.

Requirements

  • University/College degree (life science preferred) or certification in an allied health profession from an accredited institution.
  • 10+ years of work experience in clinical research, including a strong working knowledge of ICH-GCP guidelines and all other applicable guidelines and regulations.
  • 1-2 years of people management experience is an added advantage.
  • Candidates without a life sciences background but with relevant domain knowledge or experience may be considered if deemed appropriate for specific tasks and activities.


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