Deputy Director of R&D (Governance)

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Extract from JD

3.1    Management and Leadership - overall operational and management responsibilities for the services provided through the research governance, contracts and performance data teams 

•    responsible for the governance oversight of research studies/trials being delivered across the Trust, compliance with research regulations ensuring safety of participants and protecting the integrity of the data.  Ensure high-quality research governance services are provided to investigators undertaking research.  Requires efficient/effective systems/processes and strong collaboration/coordination with the Trust’s support departments, corporate services and research partners. 

•    responsible for the timely/thorough review of research sponsorship of research studies/trials on behalf of the Trust.  Ensure the implementation of proportionality across the sponsorship and audit processes. Using extensive influencing skills to be responsible for negotiating research governance, sponsorship and management decisions across the Trust and KHP.

•    Provide high-quality expert advice on regulatory applications to HRA and resolve any issues that emerge. 
  
•    Establish KPIs for the research governance/contracts functions ensuring investigators receive a timely service in relation to research governance approvals. Manage delivery of the services in relation to the KPIs, making service improvements across all teams to be responsive to the needs of investigators and meet UK-wide performance indicators. 

•    Management of complex regulatory issues for research studies making decisions based upon evidence about research compliance and risks, using expert knowledge in relation to the research regulatory requirements and environment.  

•    point of contact for complaints/escalations in relation to research governance/approvals processes/research contracts/agreements.  Manage complex conflicting views with investigators, partners and third-parties and negotiate/influence in order to resolve matters of concern.

•    Undertake investigations into alleged research misconduct/non-compliance, working collaboratively across R&D and partner organisations.  Required to communicate highly complex, sensitive and/or contentious information, maintaining confidentiality and being sensitive to organisational risks.

•    Deliver high-quality, accurate, non-financial reporting of activity data for internal and external reporting purposes. External reporting includes NIHR research infrastructure awards and our research performance for delivery of research studies.  Internally, to report performance to Clinical Directorates/Groups, Trust Board and sub-committees.    

•    Represent the Trust at local Network and national level in relation to research governance and research management.

3.2    Strategy and Policy Developments
•    Develop and implement effective systems/policies/standard operating procedures for the Trust’s research in relation to the national research governance approval systems/national legislation/regulations. Includes the development of researcher-friendly tools/templates/guidance in the setting-up of research to support researchers across GSTT/KCL in their role as an investigator.
 
•    Develop and implement strategies for robust governance arrangements and management systems to ensure Trust compliance with all relevant regulations/legislations. Lead on collaborative partnership working with the KHP Clinical Trials Office  and the Joint Research Office to ensure all Trust research is compliant.

•    Knowledgeable in relation to local and national changes/developments/initiatives relating to research governance, contracting and performance reporting by the DHSC, NIHR and South London RRDN advising on developments, any implications and lead on taking forward new ways of working.

•    Operational planning of the research governance service, including identification of areas of improvement in the management of research and delivery, to take the lead on strategic developments to ensure improvements are implemented across the Trust. This may be new Trust policies or broader in remit across KHP .

•    Lead in working collaboratively with KCL and the Joint Research Office Director in the strategic development of the GSTT/KCL joint office developing new ways of working.    

•    Accountable for the management of the R&D central database/local portfolio management system EDGE,  lead on proposing and implementing new R&D databases systems and software that fulfil national/local performance reporting requirements.  Lead on developing EDGE in order to meet the needs of investigators, ensuring access to real-time data to support rapid approval of research studies and modernising operations to allow accurate reporting of statutory R&D performance indicators.

•    Develop and refine data management processes in order to improve reporting of research data supporting strategic initiatives to improve research performance. Analyse complex facts and situations, providing an interpretation and comparison of options.

3.3 Quality management

•    ensure GSTT and KCL co-sponsored research is undertaken to the highest ethical standards; ensure the team effectively collaborate with KHP Clinical Trial Office Quality Team in MHRA compliance.

•    develop and implement a proportionate research audit program and oversee all research audits/sponsor oversight systems, reporting into the R&D Risk and Governance Committee.  Ensure internal research audits are completed and lessons learnt are implemented across the Trust promoting a strong quality culture.
   
•    ensure GSTT remains ‘inspection ready’ by Regulatory Bodies supporting the KHP Clinical Trials Office Quality Team in regulatory inspections and oversee any corrective and preventative actions ensuring they are fully implemented to support compliance with regulatory requirements.

•    provide Trust/R&D Board reports in relation to the R&D Governance, Performance and Contracts functions, providing  analyses of R&D governance risk along with plans and proposals for service improvements.

•    ensure a continuous program of service improvement is implemented to provide a good customer experience for those seeking sponsorship review or Confirmation of Capacity to undertake research within GSTT.

•    Ensure the R&D contracts team have quality management systems in place e.g. suite of template agreements, contracts SOP/working instructions, internal and external guidance and tools to manage the non-commercial research contracts function.
 
3.4 Financial management:

Responsibility for financial management of the R&D teams’ budgets, approving grant applications involving the Trust in line with the Trust’s SFIs.

•    Ensure compliance with the Trust’s SFIs in relation to the execution of research agreements and contractual negotiations via the Research Contracts team.

•    Operational responsibility for delivering a streamlined research grant funding application procedure and guidance with the R&D finance team.
•    Lead on planning, implementing and overseeing the Trust’s research grant costing systems and processes to in order to improve efficiency, maximise income and reduce the financial risk associated with non-commercial research across GSTT.   
•    Ensure the processes between R&D contracts team and R&D finance are efficient including liaising with the KCL post-award team.

•    Hold delegated authority to approve research grants on behalf of GST as Trust sponsor representative and support strategic bids.

•    Responsibility for the financial management of research governance, contract & performance teams’ function, identify service savings and implementing cost improvement plans and develop business cases when there are changes in service needs. 

•    Delegated signatory rights of up to £25k.

•    Work with R&D finance to ensure budgets are up to date and accurate; identify changes to budgets. 

3.5 Communication & Networking:

Act as the Trust lead/content expert for showcasing the R&D governance and regulatory aspects of our research portfolio, showcasing the organisations research performance, providing advice and expert opinion. 

•    Ensure that research governance content, performance data and process systems information available to via digital “front doors” is up to date, relevant and of high quality. 

•    support planning and delivery of public-facing communications and engagement events to showcase GSTT research, promote GSTT as an outstanding location to deliver research, to both internal and external audiences . 

•    Establish effective communications/working relationships with the Clinical Groups R&D Committees re reporting and resolving issues related to their R&D delivery activity, research governance processes and statutory reporting information.

•    Develop and deliver formal training and presentations pertinent to research and research data performance across the Trust and KHP.

•    Represent R&D in meetings, committees and Boards across the Trust acting as the technical expert in relation to R&D governance, assurance and research performance and externally. 

3.6 Education, training and professional development: 

•    Maintain a system of regular performance review/appraisals for all staff, ensuring training and development needs are identified and met in line with Trust Workforce policies. 

•    Ensure a comprehensive induction and role specific training programmes meets the needs of all staff across the research governance, contracts and data performance teams.
 
•    Lead by example and act as a positive role model for all staff, taking responsibility for their own professional development.

•    Develop a supportive and facilitative departmental culture across all teams that promotes Trust values and promotes diversity.