Senior Clinical Trial Manager

Popscience Limited ,
London, Greater London
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Overview

Site Engagement Manager (Clients job title ) We are delighted to offer this new opportunity as a Site Engagement Manager with one of our partners who have offices in 6 countries for this new career opportunity as a Site Engagement Manager you can be office based In Marlow or London but expect to be traveling too so a full Uk driving licence and car are essential. You will need to have demonstrable experience of working in healthcare research in the pharmaceutical industry or clinical research organization and specifically experience of delivering non-interventional studies or audits. Knowledge of structure and function of the NHS and UK healthcare environment, demonstrable working knowledge of GCP to apply for this opportunity. As the Site Engagement Manager, You will be working in healthcare communications and market access within an established business who already work with most of the world's top 40 pharmaceutical companies, across a broad client base including biotechnology and medical devices. Their therapeutic range is broad, with particular strength and focus on oncology, rare diseases and specialist medicines. Recognised as a leader in the real world evidence arena for nearly twenty years, they work in strategic partnership with the pharmaceutical industry, healthcare and academia on RWE projects that drive improvement in healthcare delivery. As part of the team, you'll be responsible for the following activities: To manage the implementation of real-world data collection projects for both NHS and pharmaceutical industry clients in accordance with company policies and procedures and SOPs. More specifically, the role will involve centre feasibility and recruitment, obtaining central and local study approvals, site management and high-quality data generation activities within both the UK primary and secondary care setting. Here's an Idea of what you will be doing : - Responsibility for managing sites for RWE studies across the UK, to client timelines and budgets - In liaison with the Global Project Manager (GPM), formation and implementation of appropriate action plans, to optimize project delivery - Development of strong working relationships with study centre, via regular and effective communication -Ongoing tracking of project activities, timely monthly reporting of project deliverables to the Global Project Manager (GPM), to ensure accurate recognition of revenue - Preparation and submission of ethics and local/national approvals, through to successful completion. Liaison with HRA and set up of NHS site contracts - To conduct site feasibility visits/calls/assessments - To conduct site initiation visits, (SIV), source data verification (SDV), monitoring visits (which may be remote or on site), close out visits in the UK - Data collection of RWE from centres to required quality standards and within project timelines as required - Developing data collection rules to ensure consistency between researchers to enable effective data cleaning process - Working with the data management team to prepare, set up and test data management system across projects - Carrying out data collection and SDV within the NHS in accordance with study protocols, and SOPs - Facilitation of data monitoring and checking activities. - Facilitation of data cleaning and centre query process alongside the data management team - Management of data queries through to resolution - Management of centre-related pass through budget, tracking of the budget and reporting on centre budget status to Global Project Manager - Regular site liaison to provide effective, motivational support to the clinical team at study centres including Principal and Chief Investigators throughout projects - Oversee the setup of project site files at UK sites - Oversee set up of UK project files for the project master file, as per SOP, and thereafter maintain throughout projects - Maintain thorough working records of project operational activities for internal use and for presentation to clients, complying with company SOPs and GDPR requirements You should recognise yourself here: - Knowledge of structure and function of the NHS and UK healthcare environment - Knowledge of ethics submission process, NHS regulatory approval processes, and site set up experience - Healthcare service, pharmaceutical product or clinical knowledge and experience - Demonstrable relevant experience in a similar role - Demonstrable working knowledge of GCP - Graduate or relevant healthcare qualification - Are passionate about client-focused delivery of high-quality real world research to really make a difference - Thrive in a fast-paced, dynamic and client-focused consultancy environment - Demonstrable experience of working in healthcare research in the pharmaceutical industry or clinical research organisation and specifically experience of delivering non-interventional studies or audit - Willingness to travel - IT literate - working knowledge of Word, Excel and PowerPoint essential - Car owner with full driving license cra RWE DATAMANGER CTA implementation This job was originally posted as www.totaljobs.com/job/89765133

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