Director, Clinical Data Management

Director, Clinical Data Management

14 Sep
|
Labcorp Drug Development
|
iNingizimu Afrika

14 Sep

Labcorp Drug Development

iNingizimu Afrika

Job Overview:



- 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 leadership 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 Labcorp Director, Clinical Data Management 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 leadership 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.



Job Primary Functions



- Formulate short-term and long-term strategies to improve regional data management efficiencies, through collaboration with senior management.

- Act as an advisor to manage and collaborate with the Services Centers leadership (Project Management, Monitoring, Site Support, Biometrics, Drug Safety, Regulatory etc.) on all data management aspects of projects with data components.

- Identify and implement solutions to regional data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.

- Supervise, mentor and evaluate performances of data managers in regional locations and aide in staff development, career development, interpersonal skills, and achievement of competency

- Provide expertise and advice to project teams for the development of Global Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.

- Support project teams and regionally-based project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.

- Oversee regional data management services project budgets including revenue / expense forecasts and tracking.

- Collaborate with peers to establish global data management competency models and assist with the development of training programs and ensure staff achievement of position competencies.

- Responsibility with peers for the global standardization of data management processes and process improvement and efficiency and for ensuring standards are applied in regional Collaborate with peers to develop global, harmonized SOPs and specific quality processes and procedures for data management activities.

- Support business development and marketing activities at client presentations and professional

- Establish and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.

- Manage utilization and billability of regionally-based lead data managers, planning for resource allocation / recruitment based on individual skills, competencies, and availability.

- Ensure revenue and operating margin performance of the regional data management group to agreed targets.

- Provide advice and support to business development for time and cost estimates and prepare and present to potential clients on global data management capabilities.

- Support corporate business development and marketing activities at client presentations and professional seminars.

- Review literature and research technologies/procedures for improving global data management



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).



Experience:



- 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.

- Demonstrated skill for of staff exceeding 25 employees across multiple locations within a region (Europe, North America, Asia-Pacific, etc.)

- Financial management with strong financial analytical skills.

- Excellent oral and written communication and presentation skills.

- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

- Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.

- Demonstrated ability to lead by example global teams on business strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.

- Demonstrated ability to handle multiple competing priorities across clinical operating units.

- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.

- Strong managerial and interpersonal skills.

- Candidates must be fluent in English language (both verbal and written)



NO AGENCIES PLEASE



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, Associate Director, Clinical Data Management, Director, 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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