Practicante de Monitoreo

MSD Malaysia; Lima Metropolitana; Híbrido; PEN 68.000 - 105.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

Hybrid Work Arrangements

VISA Sponsorship

Descripción de la vacante

Merck & Co., Inc. is seeking an Intern/Co-op to provide administrative and operational support to clinical study teams under the CRA Manager. Focus areas include monitoring KPIs, ensuring eTMF quality, and driving process improvements.

The role involves cross-functional collaboration and exposure to regulatory compliance. Responsibilities include drafting progress reports for MoH submissions, maintaining eTMF quality, and assisting with safety reporting timelines.

Formación

• Experience coordinating clinical study documentation and processes.
• Strong analytical and data visualization skills.
• Familiarity with regulatory requirements and GCP is a plus.
• Comfortable working with multiple clinical data systems and reports.

Responsabilidades

• Prepare progress reports for MoH submissions and monitor KPIs in eTMF.
• Review documents in external platforms against eTMF filings for completeness.
• Assist in collecting documents for timely eTMF uploads and version control.
• Run SUSAR reports and track safety reporting timelines with CRAs.
• Support site visits with monitors and participate in process improvements.

Conocimientos

Coordinate

Analytical thinking

Clinical research

Data analytics

Data visualization

Planning

Herramientas

Power BI

Microsoft Excel

PowerPoint

eTMF/CTMS

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 escalation of 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}

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Intern/Co-op (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/26/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.