Senior Clinical Data Analyst - UK, Romania, Poland, Hungary

<p>When our values align, there's no limit to what we can achieve.<br/> <br/>At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.</p><p></p><p></p><p><u>The role can be flexibly based in the UK, Romania, Poland, Hungary.</u></p><p></p><p>What you will do:<br/> </p><p>The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned FSP projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g., Protocol Deviation Specification, Data Validation specification, etc.<br/>The SCDA may act as a Data Management Lead where required.<br/><br/>Key Accountabilities:</p><ul><li><p>Lead/Responsible for data cleaning and data review activities e.g., query management.</p></li><li><p>Management of project timelines (including creation, review and tracking of plans).</p></li><li><p>Review of protocols and EDC Screens if required.</p></li><li><p>Support data processing activities from database setup to database lock, e.g., SAE reconciliation.</p></li><li><p>Perform user acceptance testing on study database setups.</p></li><li><p>Perform medical coding on small studies.</p></li><li><p>Track and review CRFs. Support data entry where required.</p></li><li><p>Perform and or support the setup of DM documents and ensure proper documentation e.g., CRF Completion Guidelines (CCG)</p></li><li><p>Perform/lead functional QC activities and testing.</p></li><li><p>Mentor project team members.</p></li><li><p>Be a subject matter expert when needed.</p></li></ul><p></p><p>Ideal candidate will possess:</p><ul><li><p>Bachelor’s degree as a minimum.</p></li><li><p>Fluent English.</p></li><li><p>Proven experience in clinical research (CRO/Pharma).</p></li><li><p>Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.</p></li><li><p>Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.</p></li><li><p>Excellent interpersonal, verbal and written communication skills.</p></li><li><p>Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA &amp; WHODRUG).</p></li><li><p>Good knowledge of EDC systems (e.g., DataLabs, Rave.)</p></li><li><p>Good knowledge of electronic source data capture systems (e.g. ClinBase).</p></li><li><p>Good knowledge of all DB set-up activities including but not limited to Database Configuration. Specifications, Data Validation.</p></li><li><p>Ability to work in team environment.</p></li><li><p>Good analytical skills and attention to detail.</p></li><li><p>Basic knowledge of SAS.</p></li></ul><p></p>