Senior Project Manager RWE Colombia

AI overview

Lead the planning, execution, and delivery of Real-World Evidence studies while ensuring operational excellence and regulatory compliance across global programs.

Job purpose

We are seeking a highly motivated and skilled Senior Project Manager (PM) to join our growing Real-World Evidence (RWE) team. This is a home-based role within Colombia, offering flexibility while providing the opportunity to lead regional and global studies. 
You will lead the planning, execution, and delivery of RWE studies, including non‑interventional studies, registries, chart reviews, secondary data analyses, low-interventional studies and pragmatic research. This role ensures operational excellence, regulatory compliance, and strong stakeholder engagement across global or regional RWE programs. The PM serves as the primary point of accountability for timelines, budget, quality, and cross‑functional coordination.

Responsibilities

In This Role, You Will
  • Oversee planning and execution of medium to large, regional or multi-regional RWE studies, ensuring speed, quality, and cost optimization.
  • Serve as the primary point of contact for clients, fostering strong relationships and customer satisfaction.
  • Drive cross‑functional integration across epidemiology, biostatistics, data science, medical affairs, regulatory, and vendor partners.
  • Develop and implement integrated study management plans.
  • Monitor project progress, mitigate and manage risks, and resolve issues proactively.
  • Ensure compliance with GEP, GVP and local regulations (LGDP, LFPDPPP, PDPL, HIPAA, GDPR, and other country specific ethics requirements), and company processes.
  • Manage project financials, including forecasting, scope changes, and revenue acceleration opportunities.
  • Mentor and support team members, promoting continuous improvement and knowledge sharing.
  • Lead bid defense presentations and contribute to study strategy development.

Experience - the ideal candidate will have

  • Bachelor’s degree in Life Sciences or related field.
  • 5+ years in project management including, +2 years Real-Word Evidence (RWE)
  • Strong knowledge of clinical study conduct, risk management and regulatory requirements.
  • Therapeutic area expertise for Infectious Disease and/or Vaccines. 
  • Previous CRO experience required.
  • Effective leadership, mentorship and management skills with attention to details;
  • Demonstrates excellent analytical, organizational and problem-solving abilities;
  • Proven ability to manage complex projects across geographies and functions.
  • Proven ability to develop and manage timelines, tasks, milestones.

Experience - you must also have these skills

  • Experience in vendor management and oversight.
  • Experience managing and tracking study budgets and financials with participation and involvement with invoice and contract review and approvals.
  • Excellent oral and written communication, presentation and interpersonal skills
  • Proficiency in MS Office and project management tools.
  • ICH GCP awareness is a plus.
  • Willingness to travel up to 20% as required.  
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