[Hiring] Associate Director, Clinical Operations/Country Manager @Precision for Medicine

Role Description

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.

• 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.

Benefits

• 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.

Company Description

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.