Associate II handling TMF operations ensuring compliance in clinical trials. Collaborating with global teams to maintain quality and adherence to regulatory standards.
Responsibilities
Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles
Process, review, and resolve rejected Trial Master File (TMF) documents
Prepare periodic TMF Quality Control checklists for review by Project Team
Perform periodic TMF Quality Control to ensure adherence to regulatory and industry best practices
Work with a variety of Electronic Document Management and electronic TMF Systems
Requirements
University Degree preferred (Life Science desirable)
Up to 1-2 year of relevant experience
Knowledge of working within a highly regulated industry (desirable)
Possess data collection, indexing and editing skills
Excellent written and verbal communication skills
Strong interpersonal skills in fast-paced, deadline oriented environment
Strong planning and organizational skills
Proficiency in Microsoft Word and Excel
General understanding of clinical research principles and processes
Develop proficiency in use of an electronic document repository or eTMF
Benefits
Collaborative and innovative workplace
Diverse and inclusive environment
Opportunities for professional development
Commitment to enabling professionals from all backgrounds to succeed
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