AD of Clinical Operations
About the position The Associate Director of Clinical Operations - Centralized Monitoring is responsible for overseeing clinical operations activities, including project management, site management, and clinical systems management. This role requires strong leadership skills to establish and direct centralized monitoring processes, ensuring compliance with regulatory requirements while managing multiple projects within budget and timelines. The position involves collaboration with various departments and requires effective communication in a matrix management environment. Responsibilities • Oversee clinical operations activities including project management, site management, and clinical systems management. • Establish the structure for centralized monitoring at the company, including directing teams and writing SOPs. • Support government or commercial contracts in multiple therapeutic areas such as infectious disease, oncology, and medical devices. • Manage project oversight for complex drug development programs, ensuring deliverables are met within budget and timelines. • Communicate effectively in a matrix management organization and represent the clinical team during cross-functional collaboration. • Provide operational expertise to support program/project level functional areas. • Collaborate with the Director and other departments on clinical operations strategy and vision. • Inform division leadership on the status of clinical programs/projects and potential issues. • Ensure documentation processes and workflows are followed within projected timelines and propose solutions to improve efficiency. • Support the company's Quality Management System policies and procedures, driving performance improvement solutions. • Contribute to corporate initiatives such as process improvement and SOP development. • Manage resources, tracking, and level of effort projections for clinical operations teams. • Participate in proposal writing for government and commercial clients, including budget development and bid defense meetings. • Support inspection readiness and assist in audit preparation and follow-up activities. • Establish risk-based quality management and centralized monitoring processes for clinical trials. • Review protocols to ensure compliance with reporting requirements for KRIs and QTLs. • Provide technical oversight and coordination for central monitoring activities. Requirements • Minimum of 10 years experience in the pharmaceutical or biotechnology industry, including experience in a Contract Research Organization (CRO) or clinical trials environment. • At least 6 years of project management or equivalent clinical trials and operations management experience. • Broad multidisciplinary understanding of pharmaceutical clinical research and development processes. • Hands-on regulatory, clinical operations, or clinical trial monitoring/management experience. • Strong leadership skills including change management, people development, and strategic thinking. • Excellent facilitation, presentation, problem-solving, and conflict resolution skills. • Advanced ability to manage team resources to achieve department objectives. • Expertise in Microsoft Word, PowerPoint, and Excel; experience with Microsoft Project is required. Nice-to-haves • Proposal writing and bid defense skills. • Background in Infectious Disease/HIV clinical trials or Oncology. • Experience in the conduct of Phase 1 protocols or prior work on a government contract. Benefits • Remote work flexibility with occasional onsite meetings. • Travel expenses covered by the company for client meetings. Apply tot his job