AD of Clinical Operations - 1400871SKI_29-4658
About the position The Associate Director of Clinical Operations will oversee clinical operations activities, ensuring effective project management and compliance with regulatory standards. This role involves leading centralized monitoring efforts, managing clinical trial activities across various therapeutic areas, and collaborating with cross-functional teams to support clinical trial strategies and objectives. Responsibilities • Oversight of clinical operations activities including project management, site management, and clinical systems management. • Support government or commercial contracts in multiple therapeutic areas such as infectious disease, oncology, and medical devices. • Manage project oversight for multiple functional areas within complex drug development programs, ensuring deliverables are met within budget and timelines. • Communicate effectively in a matrix management organization, representing 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 of processes and workflows are followed and determine actions to prevent delays. • Support the company's Quality Management System policies and drive performance improvement solutions. • Contribute to corporate initiatives such as process improvement and SOP development. • Manage line responsibilities including staff hiring and resource management. • Participate in proposal writing for government and commercial clients and budget development. • 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 for all central monitoring activities and perform central monitoring tasks. Requirements • AD level leadership experience with the ability to establish centralized monitoring structures. • Broad multidisciplinary understanding of pharmaceutical clinical research and development processes. • Hands-on regulatory, clinical operations, or clinical trial monitoring/management experience. • Strong facilitation, presentation, problem-solving, and conflict resolution skills. • Ability to mentor staff and achieve high-quality performance through risk management and corrective actions. • Strong leadership skills including change management and strategic thinking. • Advanced ability to manage team resources to meet departmental objectives. • Expertise in Microsoft Word, PowerPoint, Excel, and experience with Microsoft Project. Nice-to-haves • Proposal writing and bid defense skills. • Background in Infectious Disease/HIV clinical trials or Oncology. • Experience in conducting Phase 1 protocols or working on government contracts. Benefits • Remote work flexibility with occasional onsite meetings. • Travel expenses covered by the company. Apply tot his job