Principal Clinical Data Manager - Medical Device & Diagnostics
Labcorp Drug Development is seeking candidates for a Principal Clinical Data Manager. The Principal Clinical Data Manager can be remotely (home-based) anywhere within the United States or Canada.
- 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 system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
- Advanced planning and risk management for projects (issue escalation, resource management).
- Support recruitment of new data management candidates.
- 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.
- Supervise, mentor and evaluate performance of data managers in the location and aide in staff development, career development, interpersonal skills, and achievement of competency standards.
- Support the technical mentoring of data review staff in regional locations and aide in staff development, career development, interpersonal skills, and achievement of competency standards.
- Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
- 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 .
- 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 process.
- Understanding of global clinical development budgets and relationship to productivity targets.
- Thorough knowledge of effective clinical data management practices.
- Thorough 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.
- Minimum six (6) years relevant work experience in data management with approximately three (3) years technical supervisory experience to include data management, clinical operations, knowledge of several therapeutic areas.
- Demonstrated skill for technical management of staff exceeding 10 employees.
- Financial management of gross revenues in excess of $500K 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.
- Demonstrated 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.
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