Project Data Manager

Job Description

Project Data ManagerPermanent London£40,000Kelly Services, working on behalf of our established and specialist client are recruiting a Development Scientist to join our clients Laboratory team in east London on a permanent basis. We are keen to speak with individuals with a very strong background inmolecular biology and virology. Our client is a leading services provider in viral challenge studies and laboratory services supporting product development for customers developing antivirals, vaccines, and respiratory therapeutics. To oversee and manage projects and clinical trial data from design of the study through to final delivery of clinical datasets within the Data function. Acts as the primary Data Management Lead for assigned projects ensuring that clinical studies are carried out in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customers expectations, taking responsibilityfor resourcing and scheduling of assigned studies. Functional Lead for Data Management on assigned projects Act as point of contact for external data vendors (including Data Management vendors) Responsible for the launch, delivery and completion of all data management according to contractual agreement, relevant SOPs, guidelines and regulations Manage scope, budget, revenue recognitions Resource management for assigned studies Develop and maintain all Data Management associated documentation Responsible for overseeing and management of the database freeze and lock process in accordance with the study plans Assist in external vendor management Responsible for overseeing the setup/design of study specific e-Source database and associated documentation Responsible for ensuring completion of all user acceptance testing and associated documentation for data entry screens, electronic edit checks, data listings, import/export programs and medical coding for both eCRF and e-source systems Provide project specific training for CRAs and site staff as required Manage and oversee Quality Control (QC) process checks for eCRF database versus paper source / e-source Manage and oversee scheduled data transfers/imports/exports to/from eSource/eCRF database and associated systems Participate in and present at internal, customer, third-party, and investigator meetings or seminars Participate in development of departmental strategies, technical issue resolution and process development Participate in the delivery of applicable data management training Train and mentor data management staff Maintain proficiency in Data Management systems and processes Network with colleagues for new and/or repeat business Contribute to the development of Data Management tracking systems databases and reporting systems to support business requirements Contribute to the development and reporting of Data Management key performance indicators via status reports to project teams and management Contribute to the upkeep and maintenance of data capture standards library. Competencies and skills Detailed knowledge of the end to end Clinical Trial process Experience of working within the Data Management/Reporting environment within the Pharmaceutical industry Flexible and adaptive approach being able to rapidly re-prioritise, whilst being able to maintain a clear vision of the end goal Attention to detail, problem solving skills and innovative Training and mentoring High level of technical DM expertise Experience Experience of participation and presentation to multifunctional groups including external clients Detailed experience of Project Data Management processes Experience in the generation review and approval of data management documentation Experience in different Clinical Data Management systems Previous experience of project management methodology Familiarity with medical terminology Experience of Project Data Management budget oversight and management SAE reconciliation experience Knowledge of medical coding dictionary structures and use Detailed experience in the specification of cross functional simple and complex validation checks This is a fantastic opportunity to join a growing business, who supports personal development and growth and are currently working on some amazing projects. If you have the skills and background to succeed in this position, please apply or contact the Kelly Scientific Team for more information.Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kellys Privacy Statement. For information regarding data protection at Kelly, please visit theKelly website and have a look into the Privacy Statement.As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.