Senior Clinical Data Manager - Late Phase

Senior Clinical Data Manager - Late Phase

13 oct
|
Labcorp Drug Development
|
España

13 oct

Labcorp Drug Development

España

Job Overview:



Senior Clinical Data Manager – Late Phase



Home-Based



- 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.



Education/Qualifications:



- 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.



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.

- 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.



MORE INFORMATION AVAILABLE ON REQUEST



For a confidential discussion about this opportunity, please phone Antony McAteer on +44 (0) 7800 913 717. To apply, please click on the APPLY button. 



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, Bulgaria, Czech Republic, France, Paris, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Leiden, Poland, Portugal, Romania, Russia, Slovakia, Bloemfontein, Centurion, South Africa, Madrid, Barcelona, Spain, Ukraine, #LI-Remote,  Remote, EMEA

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