Associate Director, Clinical Operations

$107,000 - $130,000/Yr

CPC Clinical Research - Aurora, CO

Full-time - Mid Level

Remote - Aurora, CO

About the position

The Associate Director, Clinical Operations is a leadership role responsible for overseeing the Clinical Operations group, ensuring effective project management and compliance with clinical trial regulations. This position requires a self-driven leader who can foster team accountability, manage project deliverables, and maintain relationships with sponsors and vendors. The role involves mentoring team members, assessing training needs, and providing strategic input to enhance operational efficiency.

Responsibilities

• Provide oversight, management, and leadership of Clinical Operations and Trial Master File Management.
• Supervise, coach, and mentor team members reporting to this position.
• Set clear job expectations and assess training needs for team members.
• Develop and maintain long-term professional relationships with sponsors and vendors.
• Oversee quality, accuracy, and timeliness of deliverables from Clinical Operations teams.
• Interact with sponsors and vendors and participate in necessary meetings.
• Develop and manage multidisciplinary project team activities.
• Assess project issues and propose resolutions to the project team and leadership.
• Provide regular updates on staff performance, timelines, and deliverables.
• Ensure appropriate resourcing and personnel allocation for evolving business needs.
• Provide strategic input into innovations and contribute to functional area goals.
• Develop and review/approve Clinical Operations policies and procedures.
• Oversee compliance with applicable regulations and guidelines.
• Function as an Executive Clinical Operations Manager for assigned projects.
• Assist Business Development with benchmarking for budgets and proposals.

Requirements

• Nursing or BA/BS in a scientific field preferred but not required.
• A minimum of 7 years of experience in clinical trials or equivalent experience.
• A minimum of 1 year of supervisory experience.
• Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations.
• Excellent interpersonal communication skills and problem-solving abilities.
• Experience with MS Office including Project, Access, PowerPoint, SharePoint, Word, and Excel.
• Ability to work as a team member and supervise staff effectively.
• Ability to manage conflicts and resolve problems.

Nice-to-haves

• Experience in a leadership role within clinical research organizations.
• Familiarity with project management software and tools.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Paid holidays
• Paid sick time
• Vision insurance