Senior Biometrics Project Coordinator
- Experience Level
- Experienced (non-manager)
- Excellent opportunity for a candidate that has some administration experienced gained within clinical trials to work as a Senior Biometrics Project Coordinator for Covance by Labcorp, a world renowned, global CRO
- You will provide support for Data Monitoring Committees (DMCs) / DSMB committees and project teams
- For candidates that perform well, opportunities to progress
- Home based anywhere in the UK or work office based in Edinburgh, Leeds or Maidenhead
- Candidates must be fluent in English language (both verbal and written)
- Previous experience of working in an administration capacity within clinical research essential
Covance by Labcorp is seeking graduates (preferably life science) with a passion for clinical research to work as a Senior Biometrics Project Coordinator. You will provide support for Data Monitoring Committees (DMCs) / DSMB committees and project teams. The selected candidate will ensure smooth completion of deliverables and provision of contracted services associated with DMC projects including member selection, contracts, meeting coordination, meeting minutes, following-up on action items and tracking project timelines and budget. This is a permanent home or office-based role anywhere in the UK. If you wish to work office based you can work from Edinburgh, Leeds or Maidenhead.
Job Primary Functions
- Coordinate and support activities for Data Monitoring Committees (DMCs) including but not limited to timeline generation, charter development, travel arrangements, meeting organization and preparation, report generation and review, meeting attendance, meeting minutes and expense reporting.
- Monitor workflow and project status on assigned projects to ensure all DMC deliverables and deadlines are met.
- Ensure compliance with project budget, actively identifying out-of-scope work and escalating potential issues to relevant individuals, as appropriate.
- Develop DMC tracking tools and reports.
- Act as a liaison between the sponsor and the DMC, interacting regularly with both them and with the internal project team.
- Conduct and minute internal DMC support team meetings.
- Provide guidance to the Covance by Labcorp project team and to clients regarding the DMC process and activities.
- Provide mentoring and quality control for less experienced DMC project coordinators.
- Maintain project-specific documentation, including, but not limited to, Study Master Files (set-up and maintenance), table mockups.
- Assist in the preparation, generation and distribution of SAS output, reports and presentations to internal and external clients.
- Perform quality control of certain DMC deliverables.
- Ensure the delivery of high quality work to internal and external clients through ongoing quality management, review and implementation of appropriate follow-up activities.
- Organize storage and archiving of project documentation.
- Perform quality control of certain Biostatistics and Statistical Programming deliverables and carry out other departmental activities as assigned.
- Carry out all activities according to the appropriate Covance by Labcorp SOPs, working within the framework of the Quality Management System and Good Clinical Practice (GCP).
- Build and maintain good working relationships within the Biostatistics and Statistical Programming department and across functional units.
- Interact with a high degree of professionalism and discretion.
- Bachelor's degree
- Previous administration experienced gained within clinical trials essential
- Ideally some knowledge of Data Monitoring Committees (DMCs)
- High degree of accuracy with close attention to detail
- Functions as a strong team player
- Ability to work efficiently and independently, with limited guidance
- Ability to effectively balance multiple concurrent priorities
- Ability to present and share information across functional areas, with clients and DMCs
- Ability to anticipate and identify problems and take appropriate action to correct
- Good customer focus
- Strong written and verbal communication skills
- Proficiency in use of standard software packages including Word, Excel, PowerPoint
- The ability to work to tight deadlines while maintaining high standards
- Ability to adhere to strict guidelines and codes of practice
- Good knowledge of the overall clinical trial process
- Good project management and organizational skills
- A professional approach at all times.
MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Peter Lewis on +44 (0) 1628 543 457 . To apply, please click on the APPLY button.
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