Practicante de Monitoreo

Merck; Lima Metropolitana; Presencial; PEN 30.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

Merck in Lima, Peru is seeking an Intern/Co-op to provide administrative and operational support to clinical study teams under the CRA Manager. You will monitor KPIs within the eTMF, ensure quality and completeness of documents, and collaborate跨-functionally to drive process improvements while ensuring regulatory compliance.

The role emphasizes learning across Regulatory, Pharmacovigilance, and Finance teams, with a hybrid working arrangement.

Formación

• Experience coordinating clinical research processes.
• Strong analytical skills and attention to detail.
• Ability to manage multiple priorities and deadlines.
• Familiarity with clinical study documentation and regulatory requirements.

Responsabilidades

• Assist in drafting progress reports for MoH submissions or notifications.
• Monitor KPIs, especially in the eTMF, and generate periodic reports.
• Review documents uploaded to external platforms against eTMF filings for completeness.
• Support collection of essential documents for timely eTMF uploads and maintain version control.
• Run SUSAR reports and share status updates with CRAs; monitor safety reporting timelines.

Conocimientos

Data Analytics

Document Management

Planning Ability

Multitasking

Herramientas

Power BI

eTMF

CTMS

Microsoft Excel

Microsoft Word

PowerPoint

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