Associate II, TMF Operations - Serbia or UK - Home-based
- Employer
- Worldwide Clinical Trials
- Location
- Belgrade, Serbia
- Salary
- Competitive
- Start date
- 22 Mar 2023
- Closing date
- 20 Apr 2023
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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 almost 2,500 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.
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
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)
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
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Company
Find out more about working for our company
Brief Company Description;
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 3,000 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.
- Website
- https://www.worldwide.com/
- Mini-site
- Worldwide Clinical Trials
- Telephone
- +44 115 956 7711
- Location
-
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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