Practicante de Monitoreo

MSD LATAM; Lima Metropolitana; Híbrido; PEN 15.000 - 18.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

MSD LATAM in Lima is seeking an Intern/Co-op to provide administrative and operational support to clinical study teams, focusing on monitoring KPIs and maintaining eTMF quality.

You will collaborate with Regulatory, Pharmacovigilance, and other functions, assist in reporting to MoH, and help drive process improvements while ensuring compliance with internal standards.

Hybrid work arrangement with exposure to multiple systems like eTMF, CTMS, and Power BI.

Formación

• Experience with clinical data management and eTMF processes.
• Knowledge of regulatory requirements and GCP basics.
• Strong analytical skills and attention to detail.
• Proficient with Microsoft Office; Power BI a plus.

Responsabilidades

• Assist in drafting reports for MoH submission.
• Monitor KPIs and maintain eTMF quality.
• Review documents across platforms to ensure alignment.
• Support data collection and version control for eTMF uploads.
• Contribute to process improvement initiatives.
• Coordinate with Regulatory, Pharmacovigilance, and other teams.

Descripción del empleo

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 elevate 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, disciplined decisions.
• Foster collaboration across teams.
• Drive results and accountability.
• Demonstrate ethics and integrity in all activities.

Optional Qualifications (if Applicable)

• Familiarity with clinical research processes and GCP.

Required Skills

Ability to Coordinate, Ability to Coordinate, Analytical Problem Solving, Clinical Research, Corporate Ethics, Customer Centricity, Customer-Focused, Data Analytics, Database Management, Data Entry, Data Visualization, Decision Making, Document Management, Ethical Standards, Health Economics, International Travel Arrangements, Learning Agility, Microsoft PowerPoint, Multitasking, Office Applications, Planning Ability, Policy Compliance, Process Improvements, Progress Monitoring, Progress Reports {+ 8 more}

Employee Status

Intern/Co-op (Fixed Term)

Flexible Work Arrangements

Hybrid

Job Posting End Date

09/26/2026

Requisition ID R417082