Project Manager

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Short info about job

Company: Swansea University

Department: Medical School

Salary: £39,324 to £46,924 per annum (pro-rata to £15,730 - £18,770 per annum) together with USS benefits. Grade 9.

Hours: Part Time

Contract type: Fixed-Term/Contract

Type / Role: Professional or Managerial

Phone: +44-1527 9216949

Fax: +44-1357 6947998

E-mail: N\A


Detail information about job Project Manager. Terms and conditions vacancy

This is a fixed-term, part-time post and the hours of work are 14 hours per week (2 days).

Main Purpose of the PostApplications are invited for the position of a Project manager in Swansea University Medical School (SUMS). This post is based in Swansea Trials Unit (STU), the Clinical Trials Unit in SUMS, and is funded by a grant from the National Institute for Health Research (NIHR) grant.

The post holder will primarily be responsible for setting up and managing trial sites for this drug trial in patients with recently diagnosed Type 1 Diabetes, with multiple centres across the UK. Work will involve supporting the Chief Investigator and others to finalise the trial protocol, obtain all regulatory approvals (ethics, R&D and MHRA) and set-up the Trial Master File. The post holder will also liaise with key researchers and Principal Investigators (PIs) at all sites primarily for the purposes of setting up the trial, training, collecting data and monitoring in accordance with STU and local standard operating procedures (SOPs). The post holder will be responsible for developing and managing all trial documentation required as part of the Trial Master File. This is a Clinical Trial of an Investigational Medicinal Product (CTIMP) which will require strict adherence to guidelines published by the Medicines and Healthcare Products Regulatory Agency (MHRA).

The post holder will also be expected to provide input to the development of the trial database in order to ensure the collection of accurate and complete high quality data for analysis of the trial. This will require experience of trial database software (e.g. MACRO4), and quality management procedures to collect high quality data and to identify errors and missing data in a timely manner.

In addition to providing senior trial management support to this trial, the post holder will also be expected to provide ad-hoc support and expertise to other Trial Managers and Data Managers working on STU-adopted studies, as well as liaising with STU core staff to ensure that studies are delivered in a timely manner and to the highest standard. As such, the post holder will need a wide range of experience in CTIMPs and non-CTIMPs, trial management and data management, as well as liaising with statisticians and others involved in trial design to allow them to adequately support STU’s diverse portfolio of trials.

Informal enquiries - Professor Hayley Hutchings; [email protected] / 01792 513412.

This post will close at midnight 15 September 2017.

Applicants will find full job details together with the online application link:

The University is committed to supporting and promoting equality and diversity in all of its practices and activities. We aim to establish an inclusive environment and particularly welcome applications from diverse backgrounds.

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