Senior Clinical Data Manager

hace 1 semana


Barcelona, España Labcorp A tiempo completo

**Senior Clinical Data Manager - Late Phase**
**Home-Based**
**Description**
- 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 in a lead clinical data management role within clinical research.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 (eCRF) 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.
- Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

**Education**:

- Additional relevant work experience will be considered in lieu of formal qualifications.

**Experience**:

- 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.- 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.

**MORE INFORMATION AVAILABLE ON REQUEST**

**Keywords**:
Labcorp Drug Development, Covance by Labcorp, Covance, Chiltern, Phases IIb-IV, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data manager, clinical data management, Clinical Data Management, Late Phase, Clinical Data Management, home based, pharma, home-based, flexible working, flexible location, field based, home based EU Anywhere, anywhere in Europe, field-based, United Kingdom, UK, Great Britain, England, Maidenhead, Reading, Berkshire, Birmingham, Cambridge, Sheffield, Manchester, Alderley Edge, Scotland, Edinburgh, Wales, Swansea, Northern Ireland, Austria, Belgium, Bul



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