Clinical Trial Manager (CTM)

Accountabilities:

• • Lead the day-to-day operational execution and oversight of assigned clinical trials, ensuring activities remain aligned with protocols, timelines, quality standards, budgets, and applicable regulations.
  • Develop and maintain study timelines, milestones, operational plans, and key deliverables.
  • Coordinate CROs, vendors, clinical sites, and external partners, ensuring effective collaboration and timely execution.
  • Monitor study progress, identify risks, issues, and potential delays, and implement appropriate mitigation strategies.
  • Ensure trial activities comply with ICH-GCP, applicable regulatory requirements, protocols, and established SOPs.
  • Collaborate with Clinical Operations, Regulatory, Medical, Data Management, Pharmacovigilance, Biostatistics, and other cross-functional teams.
  • Track study metrics, KPIs, quality indicators, and operational deliverables, following up on actions where needed.
  • Support study budgets, vendor management, financial tracking, and related operational activities.
  • Prepare and participate in study team meetings and presentations for internal and external stakeholders.
  • Communicate study status, risks, milestones, and key decisions clearly to US-based stakeholders.

  Requirements:

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline.
  • At least 3 years of professional experience in clinical research, including relevant experience in Clinical Trial Management or Clinical Operations.
  • Experience managing clinical trials within a pharmaceutical, biotechnology, CRO, or related healthcare organization.
  • Solid knowledge of ICH-GCP, clinical research processes, and applicable regulatory requirements.
  • Experience coordinating CROs, vendors, clinical sites, and cross-functional teams.
  • Strong project management, organizational, analytical, and problem-solving capabilities.
  • Ability to manage multiple priorities, risks, and deadlines effectively in a remote and international environment.
  • Excellent written and verbal communication skills, with the confidence to work directly with US-based stakeholders.
  • Advanced English proficiency at C1 level or equivalent.
  • Strong proficiency with Microsoft Office and commonly used clinical trial or project management systems.
  • Experience with global or multinational clinical trials is preferred.
  • Previous collaboration with US-based pharmaceutical clients or stakeholders is advantageous.
  • Experience in Phase I–III clinical development and electronic clinical trial systems is a plus.
  • PMP, ACRP, SOCRA, or another relevant clinical research/project management certification is desirable.

  Benefits:

  • Competitive salary paid in USD.
  • 100% remote work from Latin America.
  • Long-term professional engagement.
  • Independent Contractor arrangement.
  • 10 business days / 2 weeks of paid time off.
  • Paid US-calendar holidays.
  • Full-time working schedule aligned with EST hours.
  • Opportunity to collaborate with international clinical research teams and US-based pharmaceutical stakeholders.