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Lead Data Manager - South Africa

Covance

Lead Data Manager (Clinical Data Manager) Home-Based Get ahead in your career and make a difference in people’s lives 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. If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance. In this role, you will: - Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities. - Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data. - Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts. - Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics. - Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications. - 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. - 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. - 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. - Advanced planning and risk management for projects (issue escalation, resource management). - Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget. - Assist with goal creation and performance review assessment for data review project staff. - Maintain technical data management competencies via participation in internal and external training seminars. - Ensure project staff are trained and adhere to project-specific, global, standardized data management processes. - Identify areas for process and efficiency improvement and implement solutions on assigned projects. - Support achievement of project revenue and operating margin for data management activities to agreed targets. - Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary. - Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities. - Review literature and research technologies/procedures for improving global data management practices. - Perform other duties as assigned by manager - 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). - Additional relevant work experience will be considered in lieu of formal qualifications. - Broad knowledge of drug development processes. - Understanding of global clinical development budgets and relationship to productivity targets. - Knowledge of effective clinical data management practices. - Knowledge of time and cost estimate development and pricing strategies. - 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. - Previous years relevant work experience in data management with technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas. - Demonstrated skill for technical management of staff exceeding 5 employees. - Financial management of gross revenues in excess of $250K per year. - Excellent oral and written communication and presentation skills. - In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations. - Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies. - 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. - Demonstrated managerial and interpersonal skills Apply Now
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