Acting as the operational backbone of the CMO organization, the coordinator ensures seamless coordination, efficient communication and well-organized execution across Clinical Development, Clinical Operations, Medical Science, Regulatory Affairs and Clinical Safety. By managing schedules, meetings, documentation, trackers and collaboration tools, this role enables teams and leaders to focus on advancing clinical programs.
In addition, this role serves as the designated backup for the Executive Assistant, providing administrative support and ensuring business continuity during periods of absence or increased workload.
Key Responsibilities
- Provide high-quality administrative support to Clinical Development, Clinical Operations and Regulatory Affairs leaders, including calendar management, meeting coordination, agenda preparation and follow-up tracking.
- Coordinate complex cross-functional meetings, including trial team meetings, governance meetings, vendor meetings, Steering Committees, Advisory Boards and leadership reviews.
- Prepare, organize and distribute meeting agendas, presentations, pre reads, minutes, action logs and follow up summaries.
- Maintain awareness of key clinical milestones and proactively coordinate meeting cadence and preparation to support timely decision-making.
- Partner closely with Project Management to support clinical timelines, meeting readiness, action tracking and cross functional communication.
- Organize, maintain and track clinical documentation in accordance with company standards, GxP expectations and ICH GCP principles.
- Maintain departmental trackers, contact lists, team calendars, decision logs and other operational tools supporting Clinical Operations.
- Manage SharePoint sites, document repositories and shared folders to ensure information is accurate, accessible and well organized.
- Support preparation of regulatory submission materials, inspection readiness documentation, quality documentation and safety-related materials as requested by functional leads.
- Coordinate vendor interactions, document exchange, operational follow up and meeting logistics as needed.
- Arrange travel, expense reimbursements, conference registration, off-site meetings and workshops for Clinical Development and Clinical Operations teams.
- Coordinate administrative processes related to purchase orders, invoices, vendor onboarding, contract routing in collaboration with Finance, Procurement and Legal.
- Facilitate effective communication across Clinical Development, Clinical Operations, Medical Science, Regulatory Affairs and Clinical Safety.
- Handle confidential clinical, regulatory, quality, vendor and personnel information with discretion, and professionalism.
- Continuously identify opportunities to improve administrative processes, documentation workflows, meeting effectiveness and information flow across the CMO organization.
- Serve as backup to the Executive Assistant by providing administrative support as needed, ensuring continuity of critical business operations during absences or peak workload periods.
Clinical Development and Operations Support
- Develop and maintain a solid understanding of clinical development programs, trial teams and cross-functional clinical workflows.
- Support clinical trial activities by coordinating documentation, trial start-up materials, enrollment updates, vendor communications and leadership reporting.
- Assist with preparing materials for governance meetings, executive updates, Board presentations and business reviews.
- Ensure strong version control, document quality, confidentiality and appropriate access management across all clinical documentation.