AD of Clinical Operations

Beacon Hill Staffing Group • Lansing, MI

387d • Remote

About The Position

The Associate Director of Clinical Operations - Centralized Monitoring is responsible for overseeing clinical operations activities, including project management, site management, and clinical systems management. This role requires strong leadership skills to establish and manage centralized monitoring processes, ensuring compliance with regulatory requirements while supporting various therapeutic areas. The position involves collaboration with cross-functional teams, project oversight, and the development of operational strategies to enhance clinical trial activities.

Requirements

• 10+ years of experience in the pharmaceutical or biotechnology industry, including CRO or clinical trials experience.
• At least 6 years of project management or equivalent clinical trials and operations management experience.
• Broad multidisciplinary understanding of pharmaceutical clinical research and development processes.
• Hands-on regulatory, clinical operations, or clinical trial monitoring/management experience.
• Strong facilitation, presentation, problem-solving, and conflict resolution skills.
• Ability to mentor staff and achieve high-quality performance through risk management and corrective actions.
• Advanced ability to manage team resources to ensure department objectives are met.
• Expertise in Microsoft Word, PowerPoint, Excel, and experience with Microsoft Project.

Nice To Haves

• Proposal writing and bid defense skills.
• Background in Infectious Disease/HIV clinical trials or Oncology.
• Experience in the conduct of Phase 1 protocols or prior work on a government contract.

Responsibilities

• Oversee clinical operations activities including project management, site management, and clinical systems management.
• Direct teams and establish the structure for centralized monitoring at the company.
• 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 within projected timelines.
• Support the company's Quality Management System policies and procedures.
• Contribute to corporate initiatives such as process improvement and SOP development.
• Manage resources and track level of effort projections for clinical operations.
• Participate in proposal writing for government and commercial clients, including 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.
• Perform central monitoring activities and follow up with study teams for action resolutions.

Benefits

• Remote work flexibility with occasional onsite meetings.
• Paid travel for client meetings.

What This Job Offers

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