Practicante de Monitoreo

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, 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:

Preferred Skills:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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