Skip to main content

This job has expired

Senior Associate, TMF Operations - UK

Employer
Worldwide Clinical Trials
Location
United Kingdom
Salary
Competitive
Start date
19 Jun 2022
Closing date
17 Jul 2022

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

External Description:

SUMMARY: The Senior 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 Senior 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 and Quality Assurance.

RESPONSIBILITIES:
  • Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP); Deputize for "TMF Process Owner" where necessary; 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, Maintenance of TMF metrics and spreadsheets for assigned studies, 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 multiple Project Team members to assess project needs relevant to the TMF
  • Escalate any TMF Quality issues in a timelines manner to relevant parties, Act as a mentor to junior members of the team
  • Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions

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

REQUIREMENTS:
  • University Degreed preferred ( Life Science desirable )
  • Combination of education plus 2-5 years of relevant experience
  • Knowledge of working within a highly regulated industry (desirable) or experience of CRO/Pharmaceutical Company industry

Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

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.

 

Company info
Website
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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert