AD of Clinical Operations - 1400871SKI_3-4658

Beacon Hill Staffing Group • Little Rock, AR

405d • Remote

About The Position

The Associate Director of Clinical Operations is responsible for overseeing clinical operations activities, including project management, site management, and clinical systems management. This role requires strong leadership skills and the ability to establish centralized monitoring structures while ensuring compliance with regulatory requirements. The position involves collaboration with various departments to support clinical trial activities and improve operational efficiency.

Requirements

• AD level leadership experience with the ability to establish centralized monitoring structures.
• Broad multidisciplinary understanding of pharmaceutical clinical research and development processes.
• Hands-on regulatory, clinical operations, or clinical trial monitoring/management experience.
• Ability to mentor staff and achieve high-quality performance through risk management and corrective actions.
• Strong facilitation, presentation, problem-solving, and conflict resolution skills.
• Excellent oral and written communication skills with strong attention to detail.
• Expertise in Microsoft Word, PowerPoint, and Excel; experience with Microsoft Project is required.
• 10 years minimum experience in the pharmaceutical or biotechnology industry.

Nice To Haves

• Proposal writing and bid defense skills.
• Background in Infectious Disease/HIV clinical trials or Oncology.
• Experience in conducting Phase 1 protocols or working on government contracts.

Responsibilities

• Oversight of clinical operations activities including project management, site management, and clinical systems management.
• Support government or commercial contracts in multiple therapeutic areas such as infectious disease, oncology, and medical devices.
• Manage project oversight for multiple functional areas within complex drug development programs.
• Communicate effectively in a matrix management organization and represent the clinical team during cross-functional collaboration.
• Provide operational expertise to support program/project level functional areas.
• Collaborate with the Director and other departments on clinical operations strategy and vision.
• Inform division leadership on the status of clinical programs/projects and potential issues.
• Ensure documentation of processes and workflows are followed and determine actions to prevent delays.
• Support the company's Quality Management System policies and drive performance improvement solutions.
• Contribute to corporate initiatives such as process improvement and SOP development.
• Manage line responsibilities and staff hiring activities within the clinical operations department.
• Participate in proposal writing, budget development, and bid defense meetings.
• Support inspection readiness and assist in audit preparation and follow-up activities.
• Establish Risk-Based Quality Management and Centralized Monitoring processes for clinical trials.
• Review protocols to ensure compliance with reporting requirements for KRIs and QTLs.
• Provide technical oversight and coordination for central monitoring activities.

Benefits

• Remote work flexibility with onsite requirements for client meetings once a month.
• Travel expenses covered by the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Administrative and Support Services
• Education Level: No Education Listed