Senior Associate I, TMF Operations

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

📋 Description

• Execute RMC Lead Activities, overseeing a diverse range of intricate studies or a Sponsor portfolio of studies.

• Engage directly with various Project Team members and Sponsors to evaluate project requirements related to the TMF and provide Subject Matter Expertise (SME).

• Manage the Quality Control process, which includes planning, reporting, and addressing non-compliance as necessary.

• Contribute to the creation of project-specific TMF Quality Management Documents.

• Develop, maintain, and present TMF Key Performance Indicators along with trend analysis data to Project Teams and Sponsors.

• Assist with Regulatory and Sponsor audits, including resolving audit findings when needed.

⛳️ Requirements

• A university degree is preferred (Life Science is desirable).

• Strong understanding of clinical research principles, industry standards, and regulations related to TMF Management.

• Exhibit excellent planning and organizational skills with the ability to perform well under pressure.

• Show strong interpersonal abilities in a dynamic, deadline-driven, and rapidly evolving environment.

• Possess outstanding written and verbal communication skills to effectively convey information to both internal and external stakeholders.

• Ability to identify solutions and make informed decisions or recognize when to seek assistance to find optimal regulatory compliant solutions, particularly in complex technical scenarios.

🏝️ Benefits

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

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