Senior Clinical Data Manager - Late Phase | (Q302)

Senior Clinical Data Manager - Late Phase | (Q302)

13 oct
|
Covance Inc
|
España

13 oct

Covance Inc

España

JOB DESCRIPTION



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.

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.es/empleo/19095727/senior-clinical-data-manager-late-phase-q302-espana/?utm_source=html

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