Associate II, TMF Operations

at  Worldwide Clinical Trials

WHO WE ARE

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

WHO WE ARE

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

YOUR EXPERIENCE

• University Degree preferred ( Life Science desirable )
• Up to 1-2 year of relevant experience
• Knowledge of working within a highly regulated industry (desirable)

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

WHAT YOU WILL BRING TO THE ROLE

• 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