Lead Data Manager - Late Phase

<h2>Job Overview:</h2><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong>Lead Data Manager (Clinical Data Manager)</strong></span></p><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong>Home-Based</strong><strong><span style="color: black;"> </span></strong></span></p><p style="margin: 12pt 0in;"><span style="font-family: verdana,geneva; font-size: 10pt;"><strong><span style="color: black;">Get ahead in your career and make a difference in people’s lives</span></strong></span></p><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.  </span></p><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"> </span></p><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance. </span></p><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;"> </span></p><p style="margin-bottom: 0pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">In this role, you will: </span></p><p style="margin-bottom: 0pt;"> </p><ul><li style="color: #000000;"><span style="font-family: verdana,geneva; font-size: 10pt;">Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Advanced planning and risk management for projects (issue escalation, resource management).</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Assist with goal creation and performance review assessment for data review project staff.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Maintain technical data management competencies via participation in internal and external training seminars.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Identify areas for process and efficiency improvement and implement solutions on assigned projects.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Support achievement of project revenue and operating margin for data management activities to agreed targets.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Review literature and research technologies/procedures for improving global data management practices.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana,geneva; font-size: 10pt;">Perform other duties as assigned</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;">• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).<br />• Additional relevant work experience will be considered in lieu of formal qualifications.<br />• Broad knowledge of drug development processes.<br />• Understanding of global clinical development budgets and relationship to productivity targets.<br />• Knowledge of effective clinical data management practices.<br />• Knowledge of time and cost estimate development and pricing strategies.<br />• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.</p><h2>Experience:</h2><p style="margin: 0px;">• Minimum five (5) years relevant work experience in data management with approximately one (1) year Lead/ technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.<br />• Excellent oral and written communication and presentation skills.<br />• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.<br />• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.</p>