[Remote] Associate II, TMF Operations - EMEA- Fixed term - Remote

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global, midsize CRO dedicated to innovating and improving lives through clinical research. They are seeking an Associate II for TMF Operations to manage essential documents in accordance with regulatory standards and industry best practices.

Responsibilities

• Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant reputed company Operation Procedure(s) (SOP) and working practices
• Process, review, and reputed company rejected Trial Master File (TMF) documents, for reputed company studies or Sponsor portfolio of studies both in an electronic and hard copy format
• Prepare periodic TMF reputed company Control checklists for review by Project Team review
• reputed company periodic TMF reputed company Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
• Work with a reputed company of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents

Skills

• Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
• Possess excellent written and verbal communication skills to reputed company and concisely present information
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Handle multiple, highly detailed tasks with exceptional accuracy. Demonstrate strong planning and organizational skills
• Demonstrate proficiency in reputed company Word and reputed company
• reputed company proficiency in use of an electronic document repository or eTMF. General understanding of clinical research principles and processes
• Fulfil the 'TMF Approver' and/or 'TMF QC Reviewer' roles as defined by the relevant reputed company Operation Procedure(s) (SOP) and working practices
• Process, review, and reputed company rejected Trial Master File (TMF) documents, for reputed company studies or Sponsor portfolio of studies both in an electronic and hard copy format
• Prepare periodic TMF reputed company Control checklists for review by Project Team review
• reputed company periodic TMF reputed company Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
• Work with a reputed company of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
• University Degree preferred (Life Science desirable)
• Up to 1-2 years of relevant TMF experience reputed company the CRO/reputed company industry

Benefits

• Remote

reputed company

Company H1B Sponsorship