Director Operations

Job Specific Responsibilities:

• Manage and monitor the performance of all departments (Business Development, Clinical Operations, Clinical Data Management, Pharmacovigilance, Medical Writing, Information Technology).
• Develop and implement operational strategies of Business Development, Clinical Operations, Clinical Data Management, Pharmacovigilance, Medical Writing, Information Technology to ensure the efficient and effective delivery of CRNI services to sponsor.
• Facilitate the seamless coordination of department-related processes by overseeing the compliance, timelines, sponsor requirements, project management activities, including site feasibility, site selection, staff training, monitoring, study supply, participant recruitment, closeout, data management, pharmacovigilance, and more.
• Oversee and lead the activities of project managers, operations managers, Medical Monitor, PVG personnel and CRAs, promoting a culture of work and high performance.
• Oversee and manage daily operational activities to ensure smooth coordination in the development of protocols, ICDs, CRFs, eCRFs, diary cards, study-related plans, and other related documents.
• Ensure the Clinical Study Report is prepared within the project management timeframe, in compliance with standard and regulatory practices, and communicated to the sponsor within the specified timelines.
• Identify and manage risks associated with clinical trials and operational processes.
• Oversee the management of client relationships, ensuring that projects are delivered with full of regulatory compliance, on time, within scope, and on budget.
• Development and enforcement of SOPs, policies, manuals, plans, work instructions etc. to ensure consistency and compliance with applicable regulations.
• Develop and manage the operational budget, ensuring efficient resource allocation and cost control.
• Drive revenue growth by identifying new markets, clients, and service offerings.
• Represent the organization at industry conferences, networking events, and partnership discussions.