Clinical Data Manager I - Remote in the US or Canada

<h2≥Job Overview:</h2≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥The Clinical Data Manager I can be remotely (home-based) located anywhere within the United States or Canada.</span≥</p≥<ul≥<li style="color: #000000;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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: arial, helvetica, sans-serif; font-size: 12pt;"≥Perform other duties as assigned by management.</span≥</li≥</ul≥<p style="margin: 0in 0in 0pt;"≥ </p≥<h2≥Education/Qualifications:</h2≥<p style="margin: 0in 0in 0pt;"≥ </p≥<ul≥<li style="color: #000000;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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).</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Additional relevant work experience will be considered in lieu of formal qualifications.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Broad knowledge of drug development processes.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Understanding of global clinical development budgets and relationship to productivity targets.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Knowledge of effective clinical data management practices.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Knowledge of time and cost estimate development and pricing strategies.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥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.</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li style="color: #000000;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Demonstrated skill for technical management of staff exceeding 5 employees.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Financial management of gross revenues in excess of $250K per year.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Excellent oral and written communication and presentation skills.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Demonstrated managerial and interpersonal skills.</span≥</li≥</ul≥<p style="margin: 0px;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥#LI-REMOTE</span≥</p≥