[Hiring] Associate II, TMF Operations @Worldwide Clinical Trials

Role Description

The Records Management Compliance Department at Worldwide Clinical Trials handles the processing, maintenance, and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country-specific regulations, and industry best practices. Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team.

What you will do:

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

Qualifications

• 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.
• 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 Microsoft Word and Excel.
• Develop proficiency in use of an electronic document repository or eTMF.
• General understanding of clinical research principles and processes.

Requirements

• University Degree preferred (Life Science desirable).
• Up to 1-2 years of relevant TMF experience within the CRO/Pharma industry.

Benefits

• We love knowing that someone is going to have a better life because of the work we do.