Clinical Data Manager II/Senior Clinical Data Manager

<div class=&quot;x_elementToProof&quot;> <p class=&quot;x_elementToProof&quot;><span data-olk-copy-source=&quot;MessageBody&quot;>We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team.&nbsp; &nbsp;We can consider candidates based in the UK, Poland, Hungary, Romania, Serbia or Slovakia.</span></p> </div> <div class=&quot;x_elementToProof&quot;>&nbsp;</div> <div class=&quot;x_elementToProof&quot;> <p class=&quot;x_elementToProof&quot;>Position Summary:</p> </div> <div class=&quot;x_elementToProof&quot;>&nbsp;</div> <div class=&quot;x_elementToProof&quot;> <p class=&quot;x_elementToProof&quot;>The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.</p> </div> <div class=&quot;x_elementToProof&quot;> <p class=&quot;x_elementToProof&quot;>&nbsp;</p> </div> <div class=&quot;x_elementToProof&quot;> <p class=&quot;x_elementToProof&quot;>Essential functions of the job include but are not limited to:</p> </div> <div class=&quot;x_elementToProof&quot;> <p class=&quot;x_elementToProof&quot;>&nbsp;</p> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>May&nbsp;perform quality control of data entry</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li> <div>May&nbsp;develop CRF specifications&nbsp;from the clinical study protocol and coordinate the review/feedback from all stakeholders</div> </li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li> <div>Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.</div> </li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications</li> <li>&nbsp;</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Review and query clinical trial data according to the Data Management Plan</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Run patient and study level status and metric reporting</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Coordinate SAE/AE reconciliation</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>May assist with SAS programming and quality control of SAS programs used in the Data Management department</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Participate in the&nbsp;development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>May review Request for Proposals (RFP), proposals, provide project estimates</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Provide leadership for cross-functional and organization-wide initiatives, where applicable</li> </ul> </div> <div class=&quot;x_elementToProof&quot;> <ul> <li>Trains and ensures that&nbsp;all data management project team members have been sufficien