Principal Scientist, Haematology

<p style="text-align:left">We’re on a mission to change the future of<br />clinical research. At Perceptive, we help the<br />biopharmaceutical industry bring medical<br />treatments to the market, faster.<br />Our mission is to change the world<br />but to do this, we need people like you.</p><h2></h2><h2></h2><h2><b>What can we offer you?</b></h2><p style="text-align:left">Apart from job satisfaction, we can offer you:</p><p style="text-align:left"><br /><b>YOURSELF</b><br />• 25 days’ holiday (with the option to buy more)</p><p style="text-align:left"><br /><b>HEALTH</b><br />• Health Cash Plan<br />• Optional private health, dental insurance, and health screens<br />• Cycle to work scheme</p><p style="text-align:left"><br /><b>WEALTH</b><br />• Generous pension scheme with up to 10% employer contribution<br />• Life assurance<br />• Season ticket loan</p><p style="text-align:inherit"></p><p style="text-align:left"><b>About the role</b></p><h1><b>Job Purpose</b></h1><p></p><p>As a Principal Scientist, you will provide scientific input on projects for clinical trials where medical imaging and clinical data is used to evaluate efficacy and/or safety of investigational drugs or medical devices.</p><p></p><p>In this role, you will work with the respective project teams to lead all project related aspects of documents, application development and (where applicable) quantitative analysis workflow development, independently. Furthermore, you will, lead the development of image acquisition guidelines, medical documentation, preparation and conduct of external project team training, central reviewer training and reviewer quality control from a medical / scientific perspective in consultation with the relevant internal support and stakeholders.</p><p></p><h1><b>Key Accountabilities</b></h1><p></p><p><b>Document Development</b></p><p></p><p>Independently author internal and external facing documents and material such as: </p><ul><li><p>Standardized/Harmonized imaging parameters - Image Acquisition Guidelines (e.g. develop imaging parameters for specific clinical protocols to ensure standardization of imaging techniques in multi-center trials)</p></li></ul><p></p><p><b>Document Review</b> </p><p></p><p>Independently review and provide input to relevant project related documents such as: </p><ul><li><p>Project Plans </p></li><li><p>Site Operations Manual, if requested </p></li><li><p>Independent Review Charter </p></li><li><p>Image QC and processing instructions (QC Form) </p></li><li><p>Reviewer Manual, if applicable </p></li><li><p>Clinical Data Transfer Instructions, if applicable </p></li></ul><p></p><p><b>Prepare and conduct internal and external trainings</b> </p><ul><li><p>Independently create training material for and present to investigator sites, CRA and client (as needed) such as PowerPoint presentation, site guides on assessment criteria and imaging parameters.  </p></li><li><p>Independently create training material for and present to internal team on image acquisition parameters, quality control and image processing, e.g. image operations </p></li></ul><p></p><p><b>Support application development </b> </p><ul><li><p>Independently review requirement specifications of analysis application (including eCRF) and associated applications, and customization of relevant image viewing/analysis tools</p></li><li><p>Independently conduct User Acceptance Testing</p></li></ul><p></p><p><b>Participate in Independent Reviewer Selection</b> </p><ul><li><p>Review CVs of potential independent reviewers</p></li></ul><p></p><p><b>Prepare and conduct Independent Reviewer Trainings</b> </p><p></p><p>Independently prepare and conduct Independent Reviewer Trainings, including:</p><ul><li><p>Prepare independent reviewer Training PowerPoint slides </p></li><li><p>Review/Edit training associated documentation</p></li><li><p>Select/Prepare training and testing cases for reviewer training</p></li><li><p>Lead training of independent reviewers on the use of imaging software, analysis applications, and implementation of the review criteria </p></li></ul><p></p><p><b>Independent Reviewer Performance Monitoring</b> </p><ul><li><p>Independently perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers </p></li></ul><p></p><p><b>Quality</b></p><ul><li><p>Identify non-compliances and non-conformances</p></li><li><p>Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out</p></li></ul><p></p><p><b>Client Meetings</b></p><ul><li><p>Participate in and significantly contribute to project related client meetings</p></li></ul><p></p><p><b>Communication </b></p><ul><li><p>Effective and professional communication with internal and external stakeholders; acts as a translator as needed</p></li><li><p>Identify, evaluate, communicate and mitigates potential risks related to deliverables.</p></li><li><p>Actively maintain and disseminate knowledge in one or more identifiable specialisms.</p></li></ul><p></p><h1><b>Functional Competencies (Technical knowledge/Skills)</b></h1><ul><li><p>Ability to perform the tasks independently and able to work under own initiative</p></li><li><p>Demonstrable ability to design and deliver training to a varied and global audience at all levels</p></li><li><p>Demonstrable knowledge of medical terminology and practices</p></li><li><p>Proven understanding of research methodologies and pragmatic application in a regulated environment</p></li><li><p>Proven ability of using Microsoft Office products (including Word, Excel &amp; PowerPoint)</p></li><li><p>Excellent interpersonal, verbal and written communication skills</p></li><li><p>A flexible attitude with respect to work assignments and new learning</p></li><li><p>Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail</p></li><li><p>Must have the ability to work methodically in a fast-paced, time-sensitive environment</p></li><li><p>Demonstratable ability to apply critical thinking to problems and tasks</p></li><li><p>Ability to identify and implement process improvements</p></li><li><p>Proactively participates in skills improvement training and encourages their teams to participate</p></li><li><p><span>Maintain an up-to-date awareness of trends, tools, technology, techniques, processes and developments within the Life sciences domain</span></p></li></ul><p></p><h1><b>Experience, Education, and Certifications</b></h1><ul><li><p>MD/PhD with relevant Clinical Research experience</p></li><li><p><b>OR</b> MSc with considerable experience</p></li><li><p><b>OR</b> BSc / Undergraduate degree in Nursing / Technologist Certification with substantial experience in imaging or clinical trials</p></li></ul><p></p><ul><li><p>Solid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industry and regulated environments.  </p></li><li><p><span>Experience using tools to communicate progress to Stakeholders.</span></p></li><li><p>English: Fluent</p></li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Come as you are.</span></b><br /><span>We&#39;re proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. </span></p>