Associate TMF Operations

Employer
Worldwide Clinical Trials
Location
Belgrade, RS
Salary
Competitive
Closing date
27 Sep 2020

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Discipline
Operations
Hours
Full Time
Contract Type
Permanent
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SUMMARY: The Associate, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice. The Associate will support the delivery of department objectives in ensuring the management essential documents.

This is a global role and will require working with Worldwide Project Team members.

RESPONSIBILITIES:
  • Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP)
  • Process Trial Master File (TMF) documents for multiple 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
  • Communicate directly with Project Team members to assess project needs relevant to the TMF
  • Escalate any TMF Quality issues in a timelines manner to relevant parties
  • Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions
  • Perform additional tasks as assigned by their Line Manager

OTHER SKILLS AND ABILITIES:
  • 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
  • Work independently and with teams and can execute tasks works under general direction, seeks assistance as needed
  • Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
  • Exercise sound judgment and ability to identify decisions requiring supervisory approval
  • 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
  • Understand and adhere to corresponding Worldwide and sponsor standard operating procedures
  • General understanding of clinical research principles and processes

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

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Are You Seeking A Career With Purpose?

The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

What We Believe

At Worldwide we operate under a shared mission, vision and set of cultural values. But these aren’t just words on a page. They are a daily inspiration and a shared commitment. Because we know that when we work towards a common goal and when we bring our best selves to the job every day we can climb mountains for our customers!

Contact Us
  • 2nd Floor
  • 172 Tottenham Court Road
  • W1T 7NS
  • GB
  • 0207 121 61 61
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