临床运营/国家经理主管

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.

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