Clinical Data Management and Oversight Specialist

hace 3 días


Buenos Aires, Buenos Aires C.F., Argentina Centro de e-Learning A tiempo completo

Job Title: Clinical Data Management and Oversight Specialist

Are you passionate about data-driven insights and leadership? Do you have experience in clinical operations and a strong understanding of regulatory requirements? We're looking for a talented Clinical Data Management and Oversight Specialist to join our team

About the Role:

  • Lead the Centralized Monitoring team in performing oversight on clinical deliverables for global assigned projects.
  • Unblinded Clinical Lead for assigned studies, responsible for IP management and risk mitigation.
  • May act as Clinical Lead when not assigned to a study or at project close-out.
  • Manage project resources, including CRAs, Central Monitors, Clinical Trial Assistants, and Centralized Monitoring Assistants.

Responsibilities:

  • Manage, monitor, and complete study/site metrics trending, including trend analysis and action plans.
  • Contribute to developing the study-specific analytics strategy and advanced analytics.
  • Support project management teams in developing monitoring strategies and triggers/thresholds.
  • Attend study team and client meetings, providing inputs to clinical study teams, key decision-makers, and internal team members.
  • Develop and use study management plans, RBM tools, and templates to evaluate quality and integrity.
  • Mentor junior staff and ensure complete documentation of study-specific tools and templates.

Requirements:

  • Bachelor's degree in life sciences or related field.
  • Strong written and verbal communication skills, with advanced command of English.
  • Strong organizational, problem-solving, and decision-making skills.
  • Results-oriented approach to work delivery and output.
  • Excellent motivational, influencing, negotiating, and coaching skills.
  • Ability to work on multiple global projects and manage competing priorities.
  • Cultural awareness and understanding, with ability to lead teams and work effectively across cultures.


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