Senior Associate I, TMF Operations

This is a fully remote position, open to applicants in Argentina, +2 more countries.

📋 Description

• Lead RMC activities while managing intricate studies or a portfolio of Sponsor studies.

• Engage with Project Team members and Sponsors to evaluate TMF-related project requirements and offer Subject Matter Expertise.

• Supervise Quality Control procedures, which includes planning, reporting, and addressing non-compliance issues.

• Assist in crafting project-specific TMF Quality Management Documentation.

• Prepare, maintain, and present TMF Key Performance Indicators alongside relevant data analysis trends.

• Provide support for Regulatory and Sponsor audits and assist in resolving audit findings as needed.

⛳️ Requirements

• In-depth understanding of clinical research principles, industry standards, and regulations pertinent to TMF Management.

• Strong organizational and planning skills, with the ability to perform under pressure.

• Excellent interpersonal skills in a dynamic, deadline-driven, and rapidly evolving environment.

• Outstanding written and verbal communication abilities.

• Capability to identify solutions and make informed decisions, or consult to determine optimal regulatory compliant solutions, particularly in complex technical scenarios.

• University degree preferred, with a focus on Life Sciences being desirable.

• A combination of education and 1-3 years of relevant experience is required.

• Familiarity with working in a highly regulated industry or experience within the CRO/Pharmaceutical sector.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness benefits.

• Supportive work environment with a focus on work-life balance.