Senior DMC Project Coordinator

Summary of Responsibilities:

• Coordinate and support activities for Data Monitoring Committees (DMCs) including but not limited to timeline generation, selection of DMC members, coordination and review of DMC contracts, charter development, travel arrangements, meeting organization and preparation, 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 document internal DMC support team meetings.
• Provide guidance to the Fortrea 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[1]up and maintenance).
• 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 all activities according to the appropriate Fortrea SOPs, working within the framework of the Quality Management System and Good Clinical Practice (GCP).
• Build and maintain good working relationships within the Clinical Development Services.
• Interact with a high degree of professionalism and discretion.
• And all other duties as needed or assigned

Qualifications (Minimum Required):

• Bachelor’s degree or higher in health-related field.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 2-6 years of experience in the job discipline (includes direct experience with DMCs); preferably at least 2 years of additional relevant experience (includes experience in the pharmaceutical, biotechnology, or CRO industry in related areas, such as: Clinical, Safety, Data Management).
• 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 them.
• 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.
• An evident appreciation of the possible impact of day-to-day activities and actions on Fortrea as a business.
• A professional approach at all times.

Physical Demands/Work Environment:

• Office or home-based environment, as requested by the line manager

Learn more about our EEO & Accommodations request here.