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Clinical Project Administrator (DMC)
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Clinical Project Administrator (DMC)

Posted 24 September by PRA Health Sciences
Salary negotiable
Swansea , West Glamorgan
Permanent, full-time

Summary

One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results.

Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.

Responsibilities

The DMC (Data Monitoring Committee) is a team of specialized trained staff within a dedicated unit supporting clinical trial delivery. This dedicated unit will manage or support all Data Monitoring Committees contracted to PRA. The Clinical Project Administrator will be responsible for providing administrative, facilitation and support to the DMC component of assigned studies.

  • Provides general administrative support to the DMC and Independent Statisticians as needed including:
  • Filing all member documents including: CVs, fully executed confidentiality agreements, fully executed consulting agreements, signed conflict of interest statements and documentation of client approval of all DMC members
  • Scheduling and arranging meetings (e.g., scheduling conference rooms, coordinating logistics with meeting planning vendor).
  • Drafting and finalizing agendas for all meetings
  • Drafting minutes of Face-to- Face meetings and teleconferences
  • Ensures all required restricted access folders/portal are set up as per DMC Charter specifications
  • Arranges client review/roundtable for review of DMC documents
  • Receives and forwards members invoices for internal approval & payment
  • Draft and send DMC members disbandment letter following approval from the IRS
  • Has clear understanding of filing requirements for DMC documentation and ensures eTMF is keptup-to-date.
  • Oversees activities with internal departments, external business partners, and other external vendors
  • Assist in the Quality control of paper and electronic files

You Are

Organised, have a good attention to detail and have previous knowledge of medical terminology

  • We can consider individuals from an administrative background within the medical field or a recent graduate with a life sciences related degree.
  • Excellent written and oral communication skills
  • Read, write and speak fluent English.
  • Desired experience in the preparation of meeting minutes.
  • Experience with Microsoft Windows, word processing and spreadsheet software.
  • Desired experience in meeting facilitation
  • Demonstrated interpersonal skills
  • Ability to work with highly detailed information independently
  • Proven history of successful interaction with internal clients and relations departments in a detail oriented setting

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Required skills

  • Clinical Administration
  • Clinical Trials
  • DMC
  • Nurse
  • General Administrative Support

Reference: 40691822

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