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Trial Manager

University of Birmingham - Birmingham Clinical Trials unit (College of Medical and Dental Sciences)

Location: Birmingham
Salary: £28,762 to £31,411 p.a.
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 25th November 2022
Closes: 2nd January 2023
Job Ref: 100783

Salary: Full time starting salary is normally in the range £28,762 to £31,411, with potential progression once in post to £35,333. Grade 6

Contract Type: Fixed Term Contract until April 2024

Interviews are being held 16th January 2023

Job Summary

The Trial Manager will be a member of one or more trial working groups, responsible for the management and organisation of the trial(s) office for the conduct of large, clinical trial protocols and administration of the clinical collaborative groups.   

Main Duties

  • Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and quality standards of the Clinical Trials Unit and that appropriate records and audit trails are maintained. 
  • Ensure that the trial complies with current regulatory reporting requirements (e.g. of adverse events) to the relevant bodies e.g. competent authorities, ethics committees, investigators etc. 
  • Set up clinical sites, prepare ethics committee and regulatory submissions and ensure that the staff at participating sites understand and can comply with the protocol. 
  • Monitor progress of each site and take appropriate action to ensure good recruitment; compliance with the protocol, and the quality and timeliness of the data collection. Use initiative to tackle any practical difficulties reported by sites i.e. those which affect recruitment, protocol or Good Clinical Practice compliance or patient safety. Conduct initiation, problem solving, monitoring, quality assurance/audit visits as required. 
  • The Trial Manager may contribute to the design, analysis, publication, and presentation of the research. This may involve writing research grant applications; contributing to the design, development and feasibility/testing of protocols; case report forms; coding lists, and databases. Also, writing abstracts; designing posters. and contributing to journal articles. 
  • Responsible for the collection, processing and secure storage of the study documentation. 

Person Specification

  • Degree in a relevant Biomedical or associated subject, or’ experience within clinical research.
  • An in-depth understanding of clinical research and trial management methodology and proven ability to apply these to the development, testing and implementation of trial management procedures.
  • The ideal candidate would have significant experience of running trials in a surgical and/or international setting
  • The successful candidate may be required to travel internationally as part of the role
  • Excellent office management and clerical skills that include word processing & document layout. 
  • Experience and understanding of techniques for the management of medical research information e.g. data coding, entry validation and reporting. 
  • Ability to develop automated office procedures and to manage complex relational computer databases.
  • Experience in the design, maintenance and interrogation of complex relational databases (MS Access or SQL Server preferred). 

Informal enquires can be made to Amanda Knight at a.j.knight@bham.ac.uk

To download the details of this position and submit an electronic application online please click on the Apply Online button below, please quote the appropriate Job Ref in all enquiries, alternatively information can be obtained from https://edzz.fa.em3.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_6001/requisitions

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