Associate I – TMF Operations

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🤖 Artificial Intelligence

🧬 Biotechnology

💊 Pharmaceuticals

💰 Pre Seed Round on 2022-03

Artificial Intelligence • Biotechnology • Pharmaceuticals

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices. • Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format. • Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents. • Communicate directly with RMC Lead to report trends and issues relevant to the TMF. • Escalate any TMF Quality issues in a timely manner to RMC Lead. • Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers). • Perform additional tasks as assigned by their Line Manager.

🎯 Requirements

• University Degree preferred • Minimum 6 months of relevant TMF experience • Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries) • Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions. • Possess excellent written and verbal communication skills to clearly and concisely present information. • Work with internal teams and can execute tasks under general direction, seeks assistance as needed. • Exercise sound judgment and ability to identify decisions requiring supervisory approval. • Demonstrate proficiency in Microsoft Word and Excel. • Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills. • General understanding of clinical research principles and processes.

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events