Clinical Data Associate II - Poland (Home-based) - FSP

<p><b>When our values align, there's no limit to what we can achieve.</b><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>Parexel is currently seeking a Clinical Data Associate II to join us in Poland, dedicated to a single sponsor.</p><p></p><p>This role will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. The successful candidate will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I – IV studies. The Clinical Data Associate II has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance.</p><p></p><p>Working as a Clinical Data Associate II at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.</p><p></p><p>Expect exciting professional challenges in inspiring studies, but with time for your outside life.</p><p></p><p>This will be a fully remote home-based position. RAVE experience is strongly preferred.</p><p></p><p><b><u>Responsibilities</u></b></p><ul><li><p>Lead a small clinical study or co-lead a larger study or studies with moderate guidance.</p></li><li><p>Support several clinical studies with minimal guidance.</p></li><li><p>Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies.</p></li><li><p>Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.</p></li><li><p>Perform a thoroughly detailed review of eCRF data requirements.</p></li><li><p>Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.</p></li><li><p>Develop data edit check specifications and run data listings as required.</p></li><li><p>Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.</p></li><li><p>Develop the Data Management Plan for a clinical study.</p></li><li><p>Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.</p></li><li><p>Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries.</p></li><li><p>Perform reconciliation of header data from external data sources against the clinical database.</p></li><li><p>Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.</p></li><li><p>Assist in database upgrades/migrations including performing User Acceptance Testing.</p></li><li><p>Able to maintain study workbooks and data management files.</p></li><li><p>Perform database lock and freeze activities per company SOPs.</p></li><li><p>Provide input into the development of data management SOPs, Work Instructions, and process documents.</p></li></ul><p></p><p><b><u>Here are a few requirements specific to this advertised role.</u></b></p><ul><li><p>Bachelor’s Degree required (Master's Degree preferred) in the <span><span><span>scientific/healthcare</span></span></span> field.</p></li><li><p>At least two years’ experience in Data Management for the <span><span><span>pharmaceutical/biotechnology</span></span></span> industry.</p></li><li><p>Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors.</p></li><li><p>An understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.</p></li><li><p>Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.</p></li><li><p>Strong English language written and verbal communication skills.</p></li><li><p>Able to travel to meetings or training seminars on occasion.</p></li><li><p>Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.</p></l