Job Description Head of Project Finance

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					        Guidelines For Using The Generic Job Description For A Trial Manager

This is a comprehensive generic Job Description, and person specification, outlining the
tasks involved in managing a clinical trial, and is designed to be customised to take account
of the needs of a specific trial. This Job Description carries a recommended grade of Grade
8 (£33,779 - £40,335 (2008) or equivalent) and a job title of Trial Manager.



It is important that this Job Description is reviewed in the following way:

1.     Review and customise the Job Description to the needs of the trial

2.     Consider where the trial co-ordinating centre will be based and the services available
       to complete tasks within the host unit (i.e. computing, finance, administration
       services).

3.     Consider the type of person required to do the job (i.e. does the applicant need
       to have a clinical background or management background or both?).

4.     When your Job Description is finalised it must be graded by your institution
       (the above grade and title are recommendations).

5.     Consider the appropriate lines of authority and reporting

The UK Trial Managers’ Network and the UKCRN also offer training and mentoring schemes
to ensure that trials are managed effectively.


This Job Description is endorsed by the MRC, the NIHR-HTA Programme and several of the
major charitable funders of clinical research in the UK.




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                                GENERIC JOB DESCRIPTION

           Produced by the UK Trial Managers’ Network Career Development Group



Job title: Trial Manager

Grade: 8

Scale: £33,779-£40,335 (2008) or equivalent

Responsible to: Chief Investigator/Unit Head



Core Skills:

The post holder will have a leading role in planning, co-ordinating and completing the
project. He/she will need excellent communication, presentation skills and the ability to
organise both him/herself and others. He/she will need to demonstrate flair and innovation
when faced with challenges, excellent leadership skills and academic ability to fulfil the
requirements of this job. He/she will contribute to the strategic direction of the trial as well as
taking responsibility for the day-to day-management and will work closely with the Chief
Investigator, Project Management Group and other bodies with vested interests to ensure
the trial’s successful completion.



Expected responsibilities are outlined below:

External responsibilities:

   Maintain an up-to-date knowledge of the regulatory and governance requirements for
    clinical trials.
   Be responsible for communicating effectively with health care professionals, researchers,
    administrative staff, regulatory agencies and users of health services both nationally and
    internationally.
   Develop and maintain on-going interest in the trial among participating clinicians, health
    care professionals, health care users and other interested groups.
   Produce regular progress, safety and annual reports for statutory agencies such as
    NRES, MHRA, funding bodies and the sponsor(s).
   Prepare progress reports for the Trial Steering and Data Monitoring Committees.
   Prepare regular updates for all stakeholders using the appropriate media.



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   Maintain a database of contacts with participating clinicians and health care
    professionals and regularly evaluate the outcome of the contacts made.
   Ensure all trial procedures are developed according to Good Clinical Practice, Data
    Protection Guidelines, Freedom of Information Act and relevant national and
    international government frameworks.
   Establish and maintain a secure and validated randomisation system.
   Put in place a responsive system for SAE and SUSAR reporting according to UK
    regulations.
   Facilitate publication in relevant scientific journals throughout duration of trial.
   Facilitate promotion of the trial in the relevant media.
   Facilitate the necessary international, national, local and special approvals required by
    the trial, its staff and the various participating sites.
   Facilitate any audit, inspection or progress visit processes required by regulatory bodies,
    funder(s) or sponsor(s).


Internal responsibilities:

   Responsible for ensuring that the trial has the relevant approvals and meets the required
    governance criteria.
   Responsible for ensuring that trial staff are trained in Good Clinical Practice and have the
    required training and/or experience to meet the UK Clinical Trial regulations.
   Contribute to the development of the trial protocol and facilitate the approvals and
    notification of any amendments.
   Develop essential Trial Specific Standard Operating Procedures (TSSOP’s).
   Ensure all members of the trial team are familiar with the TSSOP’s and work to them.
   Periodically review the practice with in the trial team to ensure that the TSSOP’s are
    adhered to.
   Recruit, train, appraise and supervise the development of the trial team to ensure the
    successful completion of the trial.
   Design, produce and distribute all trial materials to participating sites.
   Establish trial procedures that ensure compliance with the protocol and monitor their
    effects regularly.
   Take overall responsibility for data management and quality assurance according to
    regulatory guidelines.
   Ensure that quality control procedures are in place for all aspects of the trial, e.g. version
    control and document histories
   Produce and maintain the trial master file


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   Take overall responsibility for quality assurance by producing, with the trial statistician
    and trial programmer, specifications for central data monitoring and reporting.
   Ensure recruitment and retention are monitored and procedures are in place for dealing
    with any problems arising from any shortfall.
   Manage the trial budget,, monitoring and recording all financial transactions to ensure
    the project adheres to financial regulations and stays within budget.


                                  PERSON SPECIFICATION

                                  Experience/Qualifications:

                                                        Essential           Desirable

Experience of managing a clinical trial or
similar health related project

Degree or Masters level qualification or
equivalent, together with substantial work
related experience

Knowledge of the regulatory and governance
requirements for clinical trials

Experience of managing budgets

Project management experience

Experience of developing, maintaining and
producing information from databases

Experience of facilitating clinical research

Evidence of presentation at meetings

Evidence of publication

Knowledge of trial methodologies, including
clinical statistics and health economics



                                        Skills/Abilities:

                                                    Essential          Desirable

Good command of written & spoken English

Excellent communication skills

Ability to prioritise and manage own and
others workloads


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Evidence of innovation

Ability to use initiative and motivate others

Ability to secure trust and influence others

Evidence of substantial problem solving skills

Evidence of good negotiating skills




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