Job Description

Under the oversight of the CRA Manager, provide administrative and operational support to clinical study teams, with a focus on monitoring KPIs, maintaining eTMF quality and completeness. Collaborate cross-functionally to drive process improvements and ensure compliance with internal standards and regulatory requirements.

Key Responsibilities

• Support the drafting of progress reports for submission/notification to the MoH
• Monitor KPIs (primarily within the eTMF), generate periodic reports, and escalate issues as appropriate.
• Review documents uploaded to external team platforms versus those filed in the eTMF, ensuring alignment and completeness.
• Support the follow-up and collection of essential documents required for timely upload to the eTMF, maintaining quality and version control.
• Run SUSAR reports and share status updates with CRAs; support oversight of safety reporting timelines and tracking.
• Accompany monitors to site visits as needed
• Actively participate in process improvement initiatives and/or projects to enhance efficiency and compliance.




• Interact with internal support functions as needed (e.g., Regulatory Team, Pharmacovigilance, Supplies, Finance, etc.)

Required Skills And Systems

• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Working knowledge of Power BI; familiarity with AI-enabled tools and other analytics/reporting platforms is a plus.
• Comfortable working with different clinical and document management systems (e.g., eTMF, CTMS).

Technical Competencies

• Strong analytical skills and attention to detail.
• Fast learner with the ability to assimilate new processes and systems.
• Solid planning and organizational skills; able to manage multiple priorities and deadlines.
• Ability to adapt to and work effectively across different systems and workflows.
• Strong interpersonal skills and collaborative mindset.

Leadership Behaviors

• Customer focus, including patient-centric thinking.
• Make fast, discipl

📌 Practicante de Monitoreo (Lima)
🏢 MSD LATAM
📍 Lima