Associate Director, Clinical Operations – Country Manager

🕒 May 21

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring) • 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 • 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 • 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

🎯 Requirements

• 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 • 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 • Experience monitoring in Oncology and complex therapeutic areas are preferred

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities