DUTIES AND RESPONSIBILITIES Project Management Identify, plan and implement service improvements to modernise real-world data res.....
DUTIES AND RESPONSIBILITIES Project Management Identify, plan and implement service improvements to modernise real-world data research practices within the Trust Lead on specific commercial real-world data projects as designated by the Research and Innovation Manager, and Director of Clinical Outcomes Identify opportunities to develop and pilot new real-world data research initiatives Plan and organise own work to ensure delivery of divisional aims and objectives Facilitate key research collaborations, ensuring that business activities are delivered to target and within agreed timelines Plan and organise a broad range of complex research activities ensuring all are completed on schedule and adjustments are made for any issues that arise Provide regular briefings on project pipelines, workloads and any additional resource requirements that may be required to fulfil demand General project management duties include: Facilitate key collaborator meetings as required Provide information and advice on appropriate dissemination of data and clinical trial implementation Monitor timelines for study set up with key stakeholders Monitor feasibilities and contract negotiations Development of Key Relationships Build and maintain productive working relationships with colleagues from operational teams within the Trust, and with a wide variety of external stakeholders Develop key working relationships with colleagues from the Research and Innovation Core Operations teams, the Research and Innovation Research Delivery teams, the Clinical Outcomes and Data Unit and various supporting departments from across the Trust Work, liaise and communicate with colleagues across the Trust to improve the quality of real-world data research processes Advise on, and when appropriate, ensure the implementation of new practice developments across the Trust which may have an impact on the effective and efficient delivery of research Provide complex information to colleagues and vendors Facilitate timely contract negotiations by liaising closely with sponsors, business development and research teams Communicate new processes to staff groups at a variety of levels Clinical Trials Management Manage clinical trial processes to ensure set up, initiation and smooth operation of a range of commercial clinical trials including but not limited to: Liaising with Trust departments regarding trial feasibility and resource requirements Processing regulatory trial submissions Attending investigator meetings in order to convey relevant information to key study teams Preparing for audit and inspections from internal and external bodies Overseeing the archiving process for clinical trials, ensuring adherence to the Trust archiving guidelines Provide communications support by acting as pivotal point of contact for key collaborators, study sponsors, clinical research organisations and specific research teams Implement effective data management by ensuring that all data submissions meet sponsor requirements Work with others to ensure that all necessary regulatory and data governance permissions are in place before any data is released for use in research programmes Develop team reporting mechanisms to measure progress against agreed performance metrics Ensure team, divisional and national study targets are achieved within agreed timeframes Financial Management Assist in the development of project costs and support contract negotiation processes with clinical trial sponsors, ensuring appropriate financial agreements are in place for each project and ensuring finances are well managed throughout projects. Ensure business processes and systems for financial management are implemented such as service line reporting, invoicing, procurement and activity logs Day-to-day project budget management duties, including administering and monitoring the project budget, acting as budget holder for project as required Adopt responsive working practices in relation to new financial processes and systems that require implementation Support standardising costs for commercial real-world data studies across the Trust to enable faster set-up times Development of Operational Processes Work in collaboration with teams from across the Research and Innovation Division, the Clinical Outcomes and Data Unit and Trust supporting departments to ensure that quality systems and new ways of working are implemented and embedded within team practices Be pro-active in monitoring the quality and effectiveness of working practices concerning real world data across the teams Maintain a clear understanding of local, regional and national policies relevant to clinical research in the NHS and uphold the Trusts standards Implement SOPs to improve working practices Ensure that systems are established for the organisation and management of research activities relating to real-word data across the Research and Innovation Division Other Key Skills Strong IT skills using various software packages including MS Word, PowerPoint, Excel and Outlook Good presentation skills to deliver information to a variety of audiences Excellent time-management and attention to detail to produce detailed accurate reports within tight timeframes Continuing Professional Development Undertake continuing personal and professional development to meet the changing demands of the job and satisfy the NHS Knowledge and Skills Framework requirements relating to the job Attend and participate in meetings and training courses as identified and/or agreed by the line manager and division Develop core leadership skills with a view to providing future management to an expanding team Freedom to Act The post holder will be guided by precedent and clearly defined occupational policies, protocols, procedures or codes of conduct. Work will be managed, rather than supervised and results outcomes will be assessed at agreed intervals by the individuals the post is accountable to. Perform any other duties within the range of skills and abilities of the post holder as required Work unsupervised and autonomously within the range of skills and abilities of the post holder, as required while adhering to the Trusts policies and procedures Develop core leadership skills with a view to providing future management to an expanding team
