Senior Clinical Data Manager – Late Phase
- You will be permanently employed by Labcorp Drug Development working in our Clinical Development Services (CDS) division working across multiple Sponsors and multiple therapeutic areas in Phases IIb to IV.
- Office based or home based anywhere in Europe or South Africa
- You must have previous experience of working in a clinical data management role within clinical research
- Candidates must be fluent in English language (both verbal and written)
Join our growing team and discover your extraordinary potential by working as a Senior Clinical Data Manager within our Global Clinical Development department.
The CDS department works across multiple therapeutic areas in Phases IIb to IV with multiple Sponsors. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Clinical Data Management expertise within a varied and dynamic environment, then this is a fantastic opportunity. This is a permanent, full-time office or home-based role anywhere within Europe or South Africa.
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.
- Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
- Support achievement of project revenue and operating margin for data management activities to agreed targets.
- Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
- 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.
- Relevant work experience in data management with technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
- 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.
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