Visiting clinical centres and monitoring trial conduct and drug accountability as 5-50% appropriate to ensure protocol compliance, good patient management and ensuring Variable Good Clinical Practice guidelines are adhered to. depending on trials allocated Acting as the main point of contact for the relevant trial/s. Additionally working with 20 % other trial managers to provide a system which ensures appropriate trial cover ‘buddy’ within SCTU. Explaining and promoting the trial (including newsletter production, website updates) to 15 % ensure wide participation and good accrual of patients. Ensuring screening data is reviewed regularly and used effectively to ensure the trial recruits at an acceptable rate at each centre. Suggesting and implementing strategies for improving recruitment. Leading and representing SCTU at relevant meetings, including Investigator Meetings 10 % and trial oversight meetings e.g. Chair or facilitator of Trial Management Group and/or Trial Steering Committee. Attendance at relevant conferences and meetings, presenting information about trials, and if appropriate presenting results. Writing and submitting trial progress reports as and when required, including reports 5 % for trial funders and REC. As appropriate, assisting with the development and maintenance of SOPs. Participation 3% in the development and maintenance of quality systems and clinical audit of research activity. Ensuring practice adheres to all relevant University policies and procedures Any duties appropriate to the band assigned by the Senior Trial Manager. This may 2 % include assisting with new grant applications. Internal and external relationships Other staff within SCTU to ensure good working relationships Chief Investigators and other members of Trial Management Group Staff at participating sites eg investigators, Research Nurses, Pharmacists Trial funders Trial oversight committees (DMEC, TSC, TMG) Sponsor representatives Regulatory agencies e.g. MHRA, Research ethics committees Pharmaceutical companies Collaborating organisations e.g. tissue banks, central laboratories, clinical suppliers, unblinding services. Special Requirements The Trial Manager will be based at Southampton General Hospital within SCTU. There will however be a requirement to travel to participating centres, meetings and conferences across the UK and possibly internationally. PERSON SPECIFICATION How to be Criteria Essential Desirable assessed
Visiting clinical centres and monitoring trial conduct and drug accountability as appropriate to ensure protocol compliance, good patient management and ensuring Good Clinical Practice guidelines are adhered to. 5-50% Variable depending on trials allocated Acting as the main point of contact for the relevant trial/s. Additionally working with other trial managers to provide a ‘buddy’ system which ensures appropriate trial cover within SCTU. 20 % Explaining and promoting the trial (including newsletter production, website updates) to ensure wide participation and good accrual of patients. Ensuring screening data is reviewed regularly and used effectively to ensure the trial recruits at an acceptable rate at each centre. Suggesting and implementing strategies for improving recruitment. 15 % Leading and representing SCTU at relevant meetings, including Investigator Meetings and trial oversight meetings e.g. Chair or facilitator of Trial Management Group and/or Trial Steering Committee. Attendance at relevant conferences and meetings, presenting information about trials, and if appropriate presenting results. 10 % Writing and submitting trial progress reports as and when required, including reports for trial funders and REC. 5 % As appropriate, assisting with the development and maintenance of SOPs. Participation in the development and maintenance of quality systems and clinical audit of research activity. Ensuring practice adheres to all relevant University policies and procedures 3% Any duties appropriate to the band assigned by the Senior Trial Manager. This may include assisting with new grant applications. 2 % Internal and external relationships Other staff within SCTU to ensure good working relationships Chief Investigators and other members of Trial Management Group Staff at participating sites eg investigators, Research Nurses, Pharmacists Trial funders Trial oversight committees (DMEC, TSC, TMG) Sponsor representatives Regulatory agencies e.g. MHRA, Research ethics committees Pharmaceutical companies Collaborating organisations e.g. tissue banks, central laboratories, clinical suppliers, unblinding services. Special Requirements The Trial Manager will be based at Southampton General Hospital within SCTU. There will however be a requirement to travel to participating centres, meetings and conferences across the UK and possibly internationally. PERSON SPECIFICATION Criteria Essential Desirable How to be assessed
Trial%20Manager%20JD%20L4%20.docx