Site Engagement Manager - Real World Evidence

About OPEN Health OPEN Health is a family of expert practices, working in partnership to drive positive change in healthcare communications and market access. Founded in 2011, OPEN Health is structured as three specialist practices, all operating under the OPEN Health brand. OPEN Health Medical Communications focused on medical affairs consultancy and content, publications planning and execution, multi-channel medical education and internal training. (previously Succinct and now including US-based Peloton Advantage) OPEN Health Patient & Brand Communications - focused on PR, advertising and patient engagement (previously The EarthWorks, Reynolds McKenzie & LEC) OPEN VIE and Pharmerit – focused on HEOR, RWE and market access (previously pH Associates, Harvey Walsh, & OPEN Access Consulting) Collaboration and connectivity was a founding philosophy and will continue to be a key driver for OPEN Health providing value for our clients and also offering an environment in which our employees can continue to thrive. We have 15 offices across 6 different countries: US, UK, The Netherlands, Germany, India and China, with over 700 employees. OPEN Health works with 90% of the world’s top 40 pharmaceutical companies, across a broad client base including biotechnology and medical devices. Our therapeutic range is broad, with particular strength and focus on oncology, rare diseases and specialist medicines. About OPEN VIE Value, Informatics & Evidence - bringing value to life OPEN VIE believes that a compelling value strategy, supported by a robust and appropriate evidence base, should be at the heart of all activities to optimize patient access to life-changing healthcare interventions. We work in partnership with the life-sciences industry in the development and delivery of robust product value strategies throughout the product life cycle at a UK, EU and Global level. Our offerings incorporate real world evidence, data analytics and value communications to support our clients in securing reimbursement and optimal commercialization of their assets. Our high-calibre, experienced team provides the full range of market access and real-world evidence services to ensure patient access to our clients’ new drugs and devices. Our specialisms include: Market access Health informatics Real world evidence Patient centred outcomes (PCO) Real World Evidence (RWE): Recognised as a leader in the real world evidence arena for nearly twenty years, we work in strategic partnership with the pharmaceutical industry, healthcare and academia on RWE projects that drive improvement in healthcare delivery. You will love this role if you: Want to establish yourself and be part of a growing and dynamic team with a strong heritage of being best in class in the real world evidence arena 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 Enjoy working across a broad range of therapeutic areas You will be a success if you: 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 As part of the OPEN VIE 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. Primary responsibilities: 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 Drive and support the process for high quality data collection by: 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 OPEN Health 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 Additional responsibilities: Contribution to the continuing achievements and annual targets of OPEN VIE by delivering project activities on time and on budget To identify areas for and contribute to process improvements Work closely with the OPEN VIE project team to understand client commercial objectives and key client deadlines to assist in the delivery of projects from start to finish Identify out of scope costs and inform GPM What you’ll bring: 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 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 Skills, Qualities & Requirements: Excellent time management and clinical site management skills Excellent organizational, verbal and written communication skills Ability to demonstrate flexible attitude, and ability to self-motivate Proven ability to work to deadlines Ability to quickly grasp new concepts A systematic, precise and thorough approach to tasks A strong proactive team worker Demonstrable ability to be solution focused Willingness to travel IT literate – working knowledge of Word, Excel and PowerPoint essential Car owner with full driving license What we offer: At OPEN Health, we are entirely dependent upon our people. They are the basis of every contract we win, every service we provide and every project we deliver. As a result, we are always on the lookout for the brightest, most enthusiastic, creative and ambitious individuals to join our teams in the UK. We work hard to create friendly and collaborative workplaces; to provide fascinating professional challenges and amazing opportunities. We have an extensive benefits package that includes: A total of 29 days holidays – 25 plus an additional 3 at our Christmas shutdown plus your birthday off Flexible start and finish times around core office hours 4 pm Friday finish A training platform that provides access to self-paced and face-to-face learning & development Group Income Protection Private Medical Insurance Employee Assistance Programme Life Assurance Enhanced parental leave Casual dress code Active CSR community supporting a range of worthwhile causes This job was originally posted as www.totaljobs.com/job/89953643