Associate II, TMF Operations

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Assume the roles of "TMF Approver" and/or "TMF QC Reviewer" as outlined by applicable SOPs and operational practices.

• Manage, evaluate, and rectify rejected Trial Master File (TMF) documents for intricate studies or Sponsor portfolios in both electronic and physical formats.

• Create periodic TMF Quality Control checklists for the Project Team's assessment.

• Conduct regular TMF Quality Control to ensure compliance with regulatory standards, ICH GCP, Sponsor requirements, and industry best practices.

• Utilize Electronic Document Management and electronic TMF Systems to examine, categorize, and process Essential Documents.

• Engage consistently with members of the Worldwide Project Team.

⛳️ Requirements

• Have skills in data collection, indexing, and editing, including the ability to follow standardized document naming conventions.

• Exhibit exceptional written and verbal communication abilities to effectively and succinctly convey information.

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

• Manage multiple, intricate tasks with outstanding precision.

• Exhibit strong planning and organizational skills.

• Demonstrate proficiency in Microsoft Word and Excel.

• Develop expertise in using an electronic document repository or eTMF.

• Have a general understanding of clinical research principles and processes.

• Possess up to 1-2 years of relevant TMF experience in the CRO/Pharma sector.

🏝️ Benefits

• A diverse and inclusive workplace.

• Collaborative and supportive teams.

• Accessible leadership.

• Equal employment opportunities.

• Exceptional employee experiences.