Template Job Description - Southampton



Last updated:October 2015JOB DESCRIPTIONPost title:Senior Quality Assurance ManagerAcademic Unit/Service:Faculty Operating Service - Clinical Trials UnitFaculty:MedicineCareer pathway:MSALevel:5Posts responsible to:Director Southampton Clinical Trials UnitPosts responsible for:Quality and Regulatory AssistantQuality and Regulatory OfficerPost base:Office-based Southampton General HospitalJob purposeThis role is responsible for the implementation and further development of the quality management system within the Southampton Clinical Trials Unit (SCTU) in line with ICH-GCP and Clinical Trials Regulations. This will require delivery of quality assurance and pharmacovigilance compliance objectives. The postholder will be part of the SCTU senior management team driving the unit forward to ensure it meets the long term strategic aims of the SCTU, the University and the Trust.Key accountabilities/primary responsibilities% TimeTake responsibility for Pharmacovigilance (PV) at SCTU. Developing and overseeing systems ensuring Serious Adverse Events (e.g. SUSAR/SARs) are reported as per regulatory requirements. 20%Take the lead in maintaining a fully compliant Quality Management System including policies and standard operating procedures sufficient to satisfy auditors. Identify where improvements should be made and lead the implementation of these, ensuring full compliance with the principles of ICH-GCP and the Clinical Trials Regulations. 20%To oversee the internal audit programme as agreed with the Director of SCTU to ensure appropriate levels of documentation to maintain adherence to all legislative / regulatory requirements. To initiate and undertake audits, including oversight of quality assurance audits on clinical trial data / pharmacovigilance data / research reports to ensure the validity of the data presented.10%To Chair the SCTU Quality Management Group, including its subgroups of: i) SOP Steering Committee - for the development and maintenance of Standard Operating Procedures (SOPs) to ensure standard working practices across the SCTU meet necessary requirements; ii) Protocol (Document Review Group) – ensuring a HRA/MHRA compliant protocol template and internal review process before sign off and; iii) risk assessment – to risk assess each new trial (and annual reviews of existing trials) to determine risk level and that appropriate levels of risk management are in place (e.g. level of monitoring). 10%To line manage the QA/PV team on a day-to-day basis, ensuring that all requirements of formal line management, career development for individuals, performance and discipline are met and to manage the workload of team members.10%To develop a national (and international) profile as an expert in Clinical Trial/Research QA, UK and European regulatory legislation and Research Governance. To input on and influence the development of agreed UK procedures and to develop long-term strategic plans for QA development within national / international clinical research in collaboration with other Clinical Trial units.10%Take the lead role in the long term strategic development of the QA and PV management within SCTU. Take the lead role in defining the audit universe and programme of internal audit at SCTU.10%Represent SCTU at meetings with the sponsors (trust and university), agreeing actions with the sponsor to ensure adequate sponsor oversight at SCTU.10%PERSON SPECIFICATIONCriteriaEssentialDesirableHow to be assessedQualifications, knowledge and experienceSkill level equivalent to achievement of a professional qualification or postgraduate degree.Proven experience of managing outcomes in a specialist field.Proven project and/or people management skills.Familiar with ISO 9002 standards or other quality audit petent in use and understanding of database software for quality management and pharmacovigilance.Experience of conducting Individual Performance Reviews, mentoring and staff developmentExpert knowledge of quality systems and regulatory requirements. Excellent understanding of research governance and EU Clinical Trials Directive.Demonstrable training in ICH-GCP.Experience in the development and maintenance of quality management systems and associated training at a senior level.In-depth knowledge of database requirements for document control and pharmacovigilance.Experience in pharmacovigilance reporting in clinical trials.Experience of collaborating and negotiating contracts/agreements with external clients.Experience of advising and influencing at senior levels.Membership of relevant professional body.PRINCE2 or similar project management qualification.Application and interviewPlanning and organisingAble to plan and manage major new projects or significant new activities, ensuring plans complement broader organisational strategy.Established organisational skills and ability to oversee a number of projects.Methodical, practical, attention to detail.Able to maintain judgement under pressure and meet deadlines.Ability to shape strategic direction.Problem solving and initiativeAble to identify broad trends to assess deep-rooted and complex issues.Able to apply originality in modifying existing approaches to solve problems.Management and teamworkAble to manage team dynamics, ensuring any potential for conflict is managed effectively.Able to formulate development plans for own staff to meet current and future skill needs.Able to provide expert guidance and advice to colleagues to resolve complex problems.To be able to work both independently and collaboratively with medical, legal and technical staffCommunicating and influencingAble to persuade and influence in order to foster and maintain relationships.Able to resolve tensions and difficulties as they arise.Verbal and writing skills for conducting workshops, drafting policies, procedures and working practice documents and advisory papers, and training staff.Able to communicate, (verbal and written), complex clinical and legal information clearly to a range of staff groups and public.Other skills and behavioursAbility to negotiate with academic and private sector stakeholders.Special requirementsJOB HAZARD ANALYSISIs this an office-based post?? YesIf this post is an office-based job with routine office hazards (eg: use of VDU), no further information needs to be supplied. Do not complete the section below.? NoIf this post is not office-based or has some hazards other than routine office (eg: more than use of VDU) please complete the analysis below.Hiring managers are asked to complete this section as accurately as possible to ensure the safety of the post-holder.## - HR will send a full PEHQ to all applicants for this position. Please note, if full health clearance is required for a role, this will apply to all individuals, including existing members of staff.ENVIRONMENTAL EXPOSURESOccasionally (<30% of time)Frequently(30-60% of time)Constantly(> 60% of time)Outside work Extremes of temperature (eg: fridge/ furnace)## Potential for exposure to body fluids## Noise (greater than 80 dba - 8 hrs twa)## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes, biohazards). Specify below:Frequent hand washingIonising radiation EQUIPMENT/TOOLS/MACHINES USED## Food handling ## Driving university vehicles(eg: car/van/LGV/PCV) ## Use of latex gloves (prohibited unless specific clinical necessity)## Vibrating tools (eg: strimmers, hammer drill, lawnmowers) PHYSICAL ABILITIESLoad manual handlingRepetitive crouching/kneeling/stoopingRepetitive pulling/pushingRepetitive liftingStanding for prolonged periodsRepetitive climbing (ie: steps, stools, ladders, stairs)Fine motor grips (eg: pipetting)Gross motor gripsRepetitive reaching below shoulder heightRepetitive reaching at shoulder heightRepetitive reaching above shoulder heightPSYCHOSOCIAL ISSUESFace to face contact with publicLone working## Shift work/night work/on call duties ................
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