Associate Director, Clinical Operations – Country Manager

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Provides strategic leadership to the Clinical Operations Department, focusing on Clinical Trial Management and Clinical Monitoring.

• Ensures that clinical trial operations are executed with high quality, in a timely manner, and are cost-effective while adhering to ICH-GCP, Federal regulations, SOPs, and other relevant regulations.

• Collaborates with executive leadership to foster the ongoing growth of the Clinical Operations Department and plays a role in the business plan at both tactical and strategic levels.

• Contributes to the formulation and revision of Clinical SOPs and departmental guidelines to maintain compliance with applicable ethical, regulatory, and clinical standards.

• Ensures that Clinical Research Associate (CRA) resources and other clinical project resources are consistently sufficient; responsible for interviewing and selecting CRAs for various studies.

• Coordinates the efforts of employees and contract Clinical Operations team members; assigns site responsibilities, monitors progress, and reviews reports and scheduling calendars.

• Aids in addressing performance issues related to employees and contract CRAs, including the potential termination of contracts when necessary.

• Represents the Clinical Operations Department on company-wide project teams.

• Assists with Clinical Operations and Project Team Meetings, which includes the creation of meeting agendas and minutes.

• Generates periodic reports to track progress and outcomes.

• Provides insights regarding Clinical Operations for proposals, budgets, and contracts; involved in bid defense meetings.

• May take part in the analysis and development of department budgets for Clinical Operations and Project Management.

• Responsible for hiring and training personnel within Clinical Operations.

• Develops job descriptions for the department.

• Complies with relevant ethical, regulatory, and clinical standards.

• May undertake additional duties as assigned.

• Adheres to applicable regulations, including FDA, ICH, and Agility Clinical Policies and Procedures.

• Acts as the primary point of contact with Client representatives and Agility Clinical personnel across Project Management, Data Management, Medical and Safety, and Biostatistics departments to ensure the efficient initiation and completion of clinical trials.

• Ensures that the standards for monitoring and reporting are consistently upheld.

• Coordinates study-specific training and other requirements for both internal and external staff, as necessary.

• Assigned to oversee full-service, large-scale, complex projects.

⛳️ Requirements

• A Bachelor’s degree in a clinical, scientific, or related field, or equivalent professional experience is required.

• A minimum of 10 years of experience in clinical research is necessary, including significant clinical and line management experience or demonstrated competencies for this role.

• Exceptional communication and organizational skills are crucial.

• Proficiency in utilizing computerized information systems, electronic spreadsheets, word processing, and email is required.

• Strong communication and interpersonal skills are essential for effective interactions with others.

• Experience in monitoring within Oncology and complex therapeutic areas is preferred.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Professional development opportunities.