This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
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 and the ability to establish centralized monitoring structures, ensuring compliance with regulatory requirements while managing multiple drug development programs. The position involves collaboration with various departments and requires effective communication within a matrix management organization.
Responsibilities
- Oversight of clinical operations activities including clinical 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 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.
- 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 experience in regulatory, clinical operations, or clinical trial monitoring/management.
- 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 department 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 requirements for client meetings.
- Travel expenses covered by the company for onsite meetings.
