Clinical Data Coder - London, United Kingdom - TFS HealthScience

Tom O´Connor

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Tom O´Connor

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Description

Overview:


TFS HealthScience is excited to be expanding our
Data Management team and we are looking for an experienced, highly motivated
Clinical Data Coder who shares our vision of providing clinical research excellence.

Our
Data Management team is a highly experienced international group of professionals led by an industry expert.


We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.

We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.


Our cores values of Trust, Quality, Flexibility, Passion and Sustainability are what makes TFS Healthscience the successful company it is today.

Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.


Together we make a difference.
TFS HealthScience is looking for a
Clinical Data Coder -
home based*:

  • in any of the TFS HealthScience locations in Europe.**
    What can we offer you?


A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities.

You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world.

TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.


Responsibilities:


Clinical Data Coder is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing tasks related to coding but also other Clinical Data Management tasks on assigned Study Teams, according to company policies, SOPs and regulatory requirements.

  • Perform coding and related activities using the appropriate tool and dictionary.
  • May perform QC of coding when the training and education allows it (e.g. Pharmaceutical degree allows to QC and review coding performed for Concomitant medication verbatim).
  • Create, edit and follow queries raised during the coding process.
  • Maintain status report about coding tasks performed during the month and upcoming months
  • Coordinate with Clinical Data Manager the coding activities in order to make sure that relevant timelines are achieved (e.g. Database lock, interim analysis, data review listings for the client when applicable)
  • Provide input into proposals which include coding activities
  • Contribute to the organization and development of processes to enhance the work at TFS (e.g. be part of internal working groups, write or review SOPs)
  • Deliver internal training related to coding activities.
  • May help on managing dictionary licenses (e.g. WHO Drug and MedDRA).
Responsible for Clinical Data Management activities for assigned studies, depending on the acquired


experience:

  • May coordinate work of other Clinical Data Management staff assigned to the project
  • Review Study Protocol
  • Develop CRF or review of sponsorgenerated CRFs
  • May develop Database specifications
  • Responsible to prepare, finalize and archive all related DM documentation
  • May define and program edit checks
  • Develop CRF completion guidelines
  • Support on the validation of database process, edit checks and trial and site settings
  • May perform validation of database, edit checks and trial and site settings in studies
  • Support the CRAs in study related questions

Qualifications:

  • Bachelor's Degree, preferably in life science, nursing or equivalent education or equivalent demonstrable experience
  • Preferable 1 years relevant experience in clinical research, drug development, pharmacovigilance department, coding activities, data management, or other healthcare environment
  • Proven coding or data management skills
  • Good written and communication skills
  • Ability to deal effectively with sponsors and internal customers
  • Ability and willingness to travel on occasion
  • TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _privacy notice_ for further details._
  • TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._

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