About this role.
Precision for Medicine seeks a senior clinical operations leader to serve as Associate Director, Clinical Operations/Country Manager for South Korea. The role leads clinical trial management and monitoring operations, including CRA resourcing, hiring, training, performance oversight, and monitoring-quality standards. It manages complex, full-service clinical studies and partners closely with clients and internal project management, data management, medical, safety, and biostatistics teams. The position requires at least 10 years of clinical research experience, substantial line-management capability, and strong knowledge of ICH-GCP and applicable regulatory requirements. Oncology and other complex therapeutic-area monitoring experience are preferred.
Role DNA
A quick view of the complexity, pace, ownership and collaboration implied by the job description.
Job Complexity
5/5Pace & Pressure
5/5Autonomy Level
5/5Communication Load
5/5Salary analysis
Estimated compensation compared with the broader US market for similar roles.
Core skills
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Sample interview questions
I establish clear SOP-based workflows, role-specific training, and routine quality reviews of monitoring reports and trial documentation. I use compliance metrics and escalation pathways to identify issues early, then implement CAPAs and verify their effectiveness through follow-up reviews.
I begin with enrollment projections, site counts, visit frequency, therapeutic complexity, geography, and required monitoring intensity. I translate these assumptions into an FTE forecast, review actual workload and monitoring-cycle data regularly, and rebalance assignments or add contingency resources before timelines are affected.
I would first review objective evidence, such as report quality, visit timeliness, protocol deviations, and stakeholder feedback. I then set a documented improvement plan with specific expectations, coaching, training, and review dates; if sustained improvement is not achieved, I partner with HR and leadership to take appropriate action while protecting study quality.
I would promptly assess root causes across enrollment, site activation, monitoring capacity, data flow, and dependencies. I would communicate a transparent recovery plan with owners, milestones, risks, and decision points, then provide regular updates so the client has clear visibility into progress and required support.
I create shared operating rhythms with clear responsibilities, decision rights, timelines, and escalation channels across clinical operations, project management, data management, medical, safety, and biostatistics. I focus discussions on patient safety, data quality, regulatory compliance, and critical-path delivery while ensuring actions and accountability are documented.
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
Due to our continued growth we are seeking a Associate Director, Clinical Operations/Country Manager to be based in South Korea.
The Associate Director, Clinical Operations/Country Manager, provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring). This role ensures the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations. The Associate Director collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels.
Essential functions of the job include but are not limited to:
- Contributes to the development and revision of Clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.
- Ensures CRA resources and other Clinical project resources are continuously adequate; interviews and selects CRAs for studies.
- Coordinates the activities of employees and contract Clinical Operations team members; designates site assignments, tracks and reviews monitoring reports and calendars. Assists in the resolution of employee and contract CRA performance issues, including termination of contracts as needed.
- Represents Clinical Operations on company-wide project teams.
- Assists with the Clinical Operations and Project Team Meetings, including development of meeting agendas and minutes.
- Produces periodic reports.
- Provides input regarding Clinical Operations for proposals, budgets and contracts; participates in bid defense meetings.
- May participate in the analysis and development of Clinical Operations and Project Management department budgets.
- Hires and trains Clinical Operations employees.
- Development of department job descriptions.
- Adheres to applicable ethical, regulatory and clinical standards.
- May perform other duties as assigned.
- Follow applicable regulations, including FDA, ICH, and Agility Clinical Policies and Procedures.
Project Related Responsibilities:
- Primary interface with Client representatives as well as Agility Clinical (Agility) personnel in the Project Management, Data Management, Medical and Safety, and Biostatistics departments to ensure the timely initiation and completion of clinical trials.
- Ensures standards for monitoring and reporting are met.
- Coordinates study specific training and other requirements for internal and external staff, as appropriate.
- Assigned to manage full-service, large-scale, complex projects.
Qualifications:
Minimum Required:
- Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required
- Must have at least 10 years of experience in clinical research, including extensive clinical and line management experience or proven competencies for this position
Other Required:
- Excellent communication and organizational skills are essential.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Excellent communication and interpersonal skills to effectively interface with others
Preferred:
- Experience monitoring in Oncology and complex therapeutic areas are preferred.
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.
Annual salary information is not provided for this position. Explore salary ranges for similar roles in our Salary Directory ›
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